EFFICACY OF AUTOLOGOUS PLATELET-

RICH PLASMA IN TONSILLECTOMY

GUIDE:DR.V.SRINIVASA MS ENT
PROFESSOR AND HEAD
DEPARTMENT OF ENT
 1.INTRODUCTION
Tonsillectomy (with or without adenoidectomy) is the common major surgical procedure performed in ENT. It is a morbid

procedure with almost all experiencing significant postoperative pain, and a 1% to 5% risk of postoperative bleeding.¹Other

complications include otalgia, poor diet, fever, and throat pain that may require additional outpatient care during the

recovery period.¹

Pain relief after tonsillectomy is an important component of postoperative care.Post-operative pain typically lasts for 7–10

days after surgery, and is moderate to severe.Many different techniques have been used to decrease post-tonsillectomy pain.

These include surgical technologies such as bipolar cautery, and plasma field dissection.Other modalities tried have been

medications such as sucralfate,nonsteroidal anti-inflammatories, and various narcotics.¹

Platelet-rich plasma (PRP), a source of multiple growth and healing factors, has been shown to accelerate wound healing
in a number of clinical situations.¹

In this study, autologous platelet-rich plasma freshly prepared was used to layer the tonsillar fossa immediately after
the surgery. Patients were then evaluted for post operative pain and healing and recovery time.
 1.1 PALATINE TONSIL
1.1.1 HISTORY

Tonsillectomy is one of the most common surgery in children. It was done for the first time by a roman surgeon Aulus Cornelius
Celsus in first centuary AD. He was the first to describe early tonsillectomy by blunt removal using fingernail or hook and to
remove them with a knife. This was followed by guillotine method by Philip Syng Physick (1768-1867), of Philadelphia in 1828
which was later modified by Morel Mackenzie who is considered to be the father of modern tonsillectomy. 11

1.1.2 ANATOMY OF TONSIL

The two palatine tonsils are located in the oropharynx's lateral wall, in between the anterior and posterior pillars.
A palatine tonsil medial and lateral surfaces as well as upper and lower poles.
The tonsil's medial surface has crypts. On the tonsil's medial surface, 12–15 crypt openings can be noticed. One of the crypts, known as crypta
magna or intratonsillar cleft, is quite large and deep and is located close to the upper part of the tonsil.
The tonsil's lateral surface exhibits a distinct fibrous capsule. The loose areolar tissue is located between the capsule and the tonsil bed.
The tonsil's upper pole extends into the soft palate. A semilunar fold covers its medial surface, running between the anterior and posterior
pillars forming supratonsillarfossa.
The tongue is connected to the tonsil's lower pole. The anterior tonsillar space is a compartment that is enclosed by a triangular fold of
mucous membrane that runs from the anterior pillar to the anteroinferior part of the tonsil. Tonsillolingual sulcus is the sulcus that
separates the tonsil from the tongue.10

EMBRYOLOGY OF TONSIL

The second branchial pouch first becomes apparent in the 4th post-conceptional week, and by the 8th week, it has undergone canalization
and begun to branch. In the seventh month of intrauterine life, lymphoid infiltration of the lamina propria takes place. Early in pregnancy,
primary follicles begin to develop, although germinal centre stimulation doesn't start until soon after birth. The development of active
germinal centres and the rapid proliferation of lymphoid components occur during the first year of life. 12
HISTOLOGY OF TONSIL

The surface of the tonsil is lined by stratified squamous non-keratinized stratified squamous epithelium 13
BED OF TONSIL

‘Tonsillar bed is formed by the following structures from medial to lateral

I. Loose areolar tissue containing Para- tonsillar vein

ii) pharyngo-basilar fascia

iii) Superior constrictor muscle

iv) Bucco-pharyngeal fascia

v) Styloglossus muscle

vi) Medial pterygoid muscle

vii) Glossopharyngeal nerve

viii) Facial artery

ix) Submandibular salivary gland

BLOOD SUPPLY OF TONSIL

The arterial blood supply of tonsil is mainly from three arteries the tonsillar branch of the dorsal lingual artery anteriorly, the
ascending palatine artery of the facial artery posteriorly, and the tonsillar branch of the facial artery entering between these two in
the lower pole of the tonsillar bed in the lower pole. In the upper pole,
ascending pharyngeal artery enters posteriorly and the lesser palatine artery enter anteriorly. Among the three
tonsillar branch of the facial artery is the largest.The venous blood drains into the peritonsillar vein then into the
lingual and pharyngeal vein and finally into the internal jugular vein. 14

NERVE SUPPLY OF TONSIL

The nerve supply of the tonsil is by the tonsillar branches of the glossopharyngeal nerve and through the descending
branches of the lesser palatine nerves. The ear symptoms in tonsillitis is through the tympanic branch of the
glossopharyngeal nerve. 14

LYMPHATICS OF TONSIL

Oropharynx acts as a barrier system filtering out the bacteria and foreign bodies with the help of tonsillar tissue and
other lymphoid tissues around oropharynx. There are no afferents in the lymphatic system. Efferents drain into upper
deep cervical lymph nodes, especially the jugulo-digastric node. 14
DISEASES OF TONSIL
Tonsillitis is more common in children. Microorganisms and food material that enter the aero digestive tract by pass the
tonsillar tissue. The medial surface of the tonsil has crypts. The food particles, microorganism and desquamated
epithelium get trapped in the crypts resulting in acute and recurrent inflammation and hence infection.

Tonsillitis is the infection of the pharyngeal tonsils, which may also involve adenoids and lingual tonsils which all forms a
part of Waldeyer’s ring. Various types

Acute tonsillitis may be either

a) superficial or catarrhal

b) follicular or cryptic

c) membranous

d) parenchymatous.
CHRONIC TONSILLITIS
Individuals often have chronic sore throat, halitosis, tonsillar hypertrophy and persistently non-tender cervical nodes. When an
individual has multiple episodes of acute tonsillitis, then it is termed as recurrent tonsillitis. This is treated with surgical management
that is by tonsillectomy.

Paradise et al, observed the efficacy of tonsillectomy in children with recurrent tonsillitis and came up with a criterion for tonsillectomy.
Recurrent tonsillitis is characterized by sore throat - 7 or more episodes in the preceding year, OR 5 or more episodes in the
preceding 2 years, OR 3 or more episodes in the preceding 3 years.
The clinical features (sore throat plus any one or more of the following symptoms quantifies to count as an episode)

a) temperature >38.30C,

b) OR tonsillar exudates,

c) Cervical lymphadenopathy (tender lymph nodes of >2 cm),

d) OR positive culture for Group A beta haemolytic streptococcus.

GRADES OF TONSIL

+ 1: Tonsils sit just outside of the tonsillar fossa with obstruction of less than

25 per cent of the airway

+ 2: Tonsils are readily seen in the airway- 25 to 50 per cent of the airway is obstructed

+ 3: Tonsils denote a 50 to 75 per cent obstruction of the airway

+ 4: Tonsils involve a greater than 75 per cent obstruction of the airway’30

MANAGEMENT OF TONSILLITIS

General measures include lots of fluids for hydration and pain relief with gargles or systemic analgesics

If the initial presentation suggests streptococcal infection, then antimicrobials are indicated on the grounds that:

1) Suppurative complications can be reduced

2) Rheumatic fever risk is reduced

4) Intra-familial spread is reduced.

MEDICAL TREATMENT

Penicillin is the antibiotic of choice for the treatment of streptococcal infections, especially for GABHS. Oral and
intramuscular administrations are effective.

a) Penicillin G or V,125-250mg/dose three times a day for 10 days is appropriate or

b) Benzathine penicillin G 600,000-12,000,000 IU once intramuscularly.

In patients resistant or allergic to pencillin, erythromycin at 20-40mg/Kg/day for 10 days may be given. Sometimes’
Azithromycin 500mg once daily for 3 days can be used since it has prolonged half-life and achieves higher
tonsillar drug concentrations’.

SURGICAL MANAGEMENT - TONSILLECTOMY

INDICATION:
‘PITTSBURG CRITERIA:
1 a) At least 3 episodes of tonsillitis per year for 3 years. 5 episodes of tonsillitis per year for 2 years. 7 or more
episodes of tonsillitis in 1 year.

b) Each episode must have been characterized by

i) Oral temperature 38.3degree Celsius.

ii) Enlarged >2cm or tender anterior cervical lymph node.

iii) Tonsillar exudates.

iv) Positive culture for group-A beta haemolytic streptococci

c) Apparently adequate antibiotic therapy must have been administered for proven or suspected streptococcal
episodes.
3. Chronic tonsillitis (minimum 6 months) persisting despite appropriate antimicrobial therapy.

4. Non urgent obstructive symptoms if tonsils very large Stretor or mouth breathing with or without episodes
of obstructive sleep apnea, muffled hot potato voice if child is at least 6 years’ old.

5. Chronic (minimum 6 months) enlargement (>2cm) or tenderness of anterior cervical lymph nodes
persisting despite appropriate antibiotic therapy’.

AS A PART OF OTHER SURGERY:

In uvulopalatopharyngoplasty

Glossopharyngeal neurectomy

Eagle’s syndrome

CONTRAINDICATIONS:

1) Presence of acute infection

4) Bleeding disorders like purpura, leukemia, aplastic anemia

5) Poliomyelitis epidemic

6) Uncontrolled systemic illnesses like diabetes, cardiac diseases

7) During menstruation

TECHNIQUES OF TONSILLECTOMY

There are two types of tonsillectomy, COLD and HOT methods.

COLD TONSILLECTOMY METHODS:

Dissection and snare method, Guillotine method, Intra capsular tonsillectomy ,Harmonic scalpel
Plasma mediated ablation technique,Cryosurgical technique 14
HOT TONSILLECTOMY METHODS:

Electrocautery, Lazer tonsillectomy ,Coblation tonsillectomy ,Radiofrequency 14

1.1.3 PLATELET-RICH PLASMA

AN OVER VIEW OF PLATELET-RICH PLASMA

In recent years, especially in the field of regenerative medicine, use of platelet-rich plasma has increased. Use of
platelet-rich plasma in surgeries is dated back to 1980’s. It was first used by oral surgeon, in an Oro-maxillary graft
surgery and published about PRP’s effect enhanced graft uptake in 1998. Recently PRP has been used in various
fields of medicine such as dermatology, orthopaedics, general surgery, ear-nose and throat surgery and has
gained popularity.
PLATELETS:

Mr. Bizzozero was the first to identify platelets and its anatomy and its role on hemostasis[36]. He was also the one
to identify megakaryocytes. Wright found megakaryocytes to be the precursor of platelets. Platelets are 2.0 to 4.0
pm in diameter, 0.5 pm in thickness, 6 to 10 femto litres in volume, with a life span of 7-10 days.
Billions of platelets are produced everyday but only few of them are used daily and remaining are cleared by
kuppfer and hepatocytes. Some type of extensions from the megakaryocytes forms platelets. These enter the bone
marrow sinusoids and are shattered into fragments by the shear force. This leads to formation of small, discoid and
anucleate platelet

Platelets are made of extensive cytoskeleton, lysozyme, ribosome, mitochondria, and smooth endoplasmic
reticulum. There are 300 different types of proteins but are not equally distributed. It also has some dense granules
like serotonin, ADP, ATP, GDP, GTP, histamine, calcium, magnesium and polyphosphate. Multiple invagination on
the surface of platelets change their shape when activated and are called open canalicular system (OCS). Once
activated the granules move to the periphery and fuse with the OCS and release their
 contents to the external environment. Dense tubular system (DTS) in the platelets, isolates calcium like that of
sarcoplasmic reticulum of muscles.

Platelets have high degree of contractility and it increases when it interacts with the actin network and non-
muscle myosin IIA

This force leads to the dense packing of the platelets in dense hemostatic plug.

Platelets are activated by physical or chemical stimuli or both. Main agonists are subendothelial collagen, von
Willebrand’s factor (vWF), thrombin, ADP and all of them put together[37]. There are two types of receptors
namely collagen and thrombin receptors. Phospholipase c signal cascade is the final pathway through these
receptors that will release calcium. Increase in the cytoplasmic calcium activates gelsolin. During this process,
granules are centralized and are released. Talin, a intracellular protein bind to main integrin and in turn binds to
fibrinogen and this is called ‘inside out signaling[37]. Integrins comes together on the platelet surface and send
signals to inside of the cell ‘outside -in’ signal, finally covert the fibrin monomers into fibres. Platelets when
activated, phosphatidylserine and few receptors are exposed to
coagulation factors creating a procoagulant surface. Further process leads to fibrin formation. Thrombus formation
has three main parts, first is the platelet collagen binding (“initiation”), recruitment and second is activation of other
platelets (“extension “) and third is the closely packed platelet rich fibrin clot (“stabilization”). Platelets are more
active in the centre of the clot and gradually reduce in the periphery. In the centre, there acts contact signalling,
i.e. direct interaction between the platelets.

PRP AND ITS CLINICAL APPLICATION IN OTHER FIELDS OF MEDICINE

The use of PRP in various clinical fields has increased like in treatment of chronic skin and soft tissue
ulcerations[38], periodontal and maxillo facial surgery, orthopedic and trauma surgery, cosmetic and plastic
surgery, spinal surgery,heart bypass surgery and burns.

PRP IN TREATMENT OF CHRONIC ULCERS:

Chronic ulcers consume a lot of time of patient’s life, with recurrent hospital visit. They are more common in lower
extremity as a result of peripheral neuropathy due to diabetes mellitus, ischemia or trauma and are usually difficult
to treat. The main aim is wound closure in an
efficient and with less time for healing. These ulcers are conventionally treated with debridement, adequate control
of infection, revascularization of ischemic tissue and reduce pressure on the wound. Managing with skin grafting
has been effective, but they lack in growth factors to enhance the healing process. In 1986, Knighton et al, showed
that autologous PRP accelerate epithelialization of tissues resulting in complete healing of chronic nonhealing
ulcers . Platelet has a large number of growth factors and cytokines that reduces inflammation and tissue repair
and finally resulting in haemostasis at sites of vascular injury.

PRP IN PERIODONTAL AND MAXILLO FACIAL SURGERY:

PRP was tried in quite a few clinical studies in bone reconstruction for dental implant placement. Patients with
osteoporosis using bisphosphonates has a reduced and delayed bone healing after oral and maxillofacial surgery
that can result in bisphosphonate induced-osteonecrosis. The use of platelet rich concentrate could be useful in
these situations
Using anticoagulants for a long time has the risk of prolonged bleeding, hence delayed healing. With the use of
PRP acting as an artificial clot, healing is dependent on
initial clot. Therefore addition of such PRP, stimulates early healing in such patients.
PRP in post tumoral reconstruction, plays a significant role because, most part of the bone will be irradiated,
mandible or maxilla devoid of healing factors in local tissue, in such case adding of PRP enhance local healing
potential and prevents osteonecrosis post surgery.

PRP IN COSMETOLOGY:

PRP is being used in cosmetology for volumetric filling[40], skin rejuvenation, acne scars and alopecia. Most
important ingredient is the a-granules, which has more than 30 bioactive substances with various growth factors as
said above along with TGF-p1, which is related to melanogenesis. Kim et al said that TGF-p1 significantly affects
melanogenesis in concentration dependent manner by decreasing melanogenesis by extra cellular signal regulated
kinase activation. PDGF helps in formation of blood vessels, collagen and extra-cellular matrix like hyaluronic acid.
This has shown to increase the skin glow and volume.

PRP IN HEART SURGERY:

Median sternotomy is the best way to access heart in most of the cardiac surgeries. Following which deep sternal
wound infection is more common which has great effects on patients, their bystanders, hospitals and payers. The
goal now is to reduce the deep sternal wound infection, but has not changed much in these years and remained
the same since 1980’s. The routine treatment being advanced surgical debridement, antibiotic irrigation and
modern VAC therapy have reduced the mortality rate but the incidence has remained the same. Many techniques
like sternal wrapping, vests, and increasing the number of sternal wires used during closure all had limited results.
The use of autologous PRP has provides good results. Growth factors in PRP, reduced the inflammation and
promoted healing. They stimulated cellular proliferation, migration, differentiation and matrix synthesis in return
they can affect chondrocyte metabolism, chondrogenesis and improve wound healing and regeneration.

NOMENCLATURE:

In the past PRP has had many names like platelet -enriched plasma, platelet-rich concentrate, autologous platelet
gel, platelet releasate, plasma rich in platelets, plasma very rich in platelets, and even plasma very very rich in
platelets. In the search for correct term, it was in 2007, the term and definition of PRP was introduced in
PubMed as a medical subject heading (MeSH) to be used for indexing articles.

CLASSIFICATION:

Ehrenfest et al. proposed a classification on PRP which was approved by multi-disciplinary consensus conference
published in 2012.

Pure Platelet-Rich Plasma (P-PRP) - this has only platelets

Leucocytes and PRP (L-PRP) - has both platelets and leucocytes forming low density fibrin post activation. Most of
the commercial PRP products are of these preparation.

Platelet Rich Fibrin (P-PRF) - doesn’t have leucocytes and form high density fibrin network.

Leucocyte and platelet-rich fibrin (L-PRF) - second generation PRP products.

METHODS OF PRP PREPARATION:

PRP can be prepared either manually or automated devices. Currently available devices include Biomet GPS II
and III, Arthrex ACP, Regen PRP and Harvest smart Prep.Each method varies with the method of producing platelet
rich plasma and the platelet concentrate in the final product also varies in their WBC and platelet concentration.
Different methods of PRP preparation has been mentioned in various studies but nothing has been standardized.
Different centrifugation techniques have been used by different authors. PRP preparation especially with table-top
centrifuge is economical and easy to use in clinical settings.

METHOD OF USE OF PRP:

There is no accurate study whether activation of platelets is needed or can be applied directly. There are many
platelet activating factors like thrombin, calcium or calcium gluconate. Some authors say platelets can be used
without activation because the collagen present in the soft tissue acts as a natural activator. This helps only when
the use is on soft tissue[50]. Few authors also have said that platelets work better without activation. PRP as a
solution can be applied through syringe or applied topically. When PRP in gel form used topically or added to bone
grafts. Platelets should be activated only at the time of use and not before that. Following which they start to
secrete growth factors for 7-8 days i.e. till their life span gets over.
Hence activation of platelets just before use is most important

COMPOSITION OF PRP

Platelets are cytoplasmic granules that lack nucleus. It contains various growth factors like platelet derived growth
factor (PDGF), Transforming growth factor (TGF -p), Insulin like growth factor (IGF-I) that are important for wound
healing. On activation, the alpha granules fuses with cell membrane and activates secretory proteins which binds
on the transport membrane receptors on the target cells like epidermal cells, mesenchymal stem cells, fibroblasts
inducing an internal signal transduction pathway, hence inducing cell proliferation, collagen synthesis, anti-
apoptosisetc.

After the initial explosion of PRP- growth factors, the platelets continue to secrete other growth factors for next 7
days of its life span. After the platelet dies, the macrophages around the region assume the function of wound
healing and start secreting growth factors. Hence platelets present in the blood clot of graft, raw area head starts
the healing, whereas PRP just fasten up the process.
’Transforming GF p (TGF p): Proliferation of undifferentiated mesenchymal cells, inhibition of lymphocyte and
macrophage proliferation, regulate endothelial, fibroblastic and osteoblastic mitogenesis, collagen synthesis and
secretion of collagenases; Mitogenous effect on other GF; Endothelial chemotaxis and angiogenesis.

Basic fibroblast GF (FGFb): Stimulates mitogenesis, growth & differentiation of mesenchymal cell mitogenesis.

Platelet derived GF (PDGF): Stimulates mitogenesis of mesenchymal cells; mitogenesis & chemotaxis of
fibroblastic, glial, smooth muscle linage cells; regulates collagenase secretion and stimulates epithelial
mesenchymal mitogenesis.

Vascular endothelial GF(VEGF): Increases angiogenesis, vascular permeability& endothelial cell mitogenesis

Connective tissue GF(CTGF): Promotes angiogenesis, chondral regeneration, fibrosis & platelet adhesion

Epidermal GF (EGF): Stimulates endothelial chemotaxis & angiogenesis; regulates secretion of collagenases,
stimulates mitogenesis of mesenchymal & epithelial cells’.
Neutrophils in the blood has few cytokines such as collagenase, gelatinase, lysozymes, elastases,
serprocidins and myeloperoxidase. Presence of matrix metalloprotease is considered as poor prognostic
factor for healing as they can degrade collagen or extracellular matrix molecules[48].

T- lymphocytes has interlukins such as IL-2,4,5,6,13,17,21, and 22, Tumor

necrosis factor-j (TNF-j). B lymphocytes contain cytokines, such as IL-6, IL-8, TNF-a and IL-1p. Monocytes are of
two phenotypes, pro inflammatory and other is proangiogenic[48].

Effects of PRP not depends on PRP alone, but also by the WBC’s. Growth factors and cytokines of platelets are
anabolic whereas WBC’s are catabolic[48] ,which finally affects the clinical outcom

PREPARATION OF PRP:

With proper informed consent of the patient, under all aseptic precautions 10ml of blood is drawn with 10ml
syringe with 1ml of anticoagulant CPDA (citrate phosphate
dextrose adenine)at the time of insertion of iv cannula, just three hours before the surgery. The collected blood is
allowed to stand for an hour. This is followed by soft spin centrifugation7, i.e. 1000 rpm for 10 min, that separates
into three layers namely bottom-most RBCs layer, topmost a cellular plasma layer which is called PPP (platelet-
poor plasma) and the intermediate PRP layer which is called the Buffy coat[3]. The above two layers are taken and
transferred to another container and made to stand for an hour and undergoes fast spin, i.e. 3000 rpm which is
much faster than the former. This allows the platelet rich plasma to settle at the bottom of the container which is
extracted and used for the study. The effect of PRP, also depends on the type of container, temperature, type of
spin and anticoagulant.

FACTORS INFLUENCING PLATELET YIELD IN PRP:

Many factors influence the PRP yield [50], right from the collection of blood and every step of preparation from
whole blood. Waters and Roberts found that even proper selection of vein is important for blood collection of PRP,
because improper insertion of syringe in the vein can reduce the amount of platelets. Studies advice the use of
large bore needle for collection of blood, to avoid
unintentional activation of PRP during the process of drawing blood.

1) CENTRIFUGATION:

Different forces like RCF and RPM along with the duration of centrifugation influence the PRP yield. It depends on
the radius of the rotor used and type of centrifuge machines, hence making it difficult to standardize a system of
preparation of PRP.

g = (1.118 x 10) R S2

where g = RCF, R - radius of rotor in centimetres, s -revolution per minute.

2) TEMPERATURE

‘Macey et al. said that preparing PRP at lower temperatures may affect platelet activation’.

3) ANTICOAGULANTS:

ACD is the choice of anticoagulant used. EDTA should not be used as it damages the platelet membrane. Citrate
phosphate dextrose adenine is also being used. During
preparation anticoagulants should be separated soon, or else it will diffuse into PPP leading to false low platelet
count.

MECHANISM OF ACTION:

Once the PRP is prepared and is activated with thrombin or any other product, they start to secrete all the
preformed growth factors within 10 minutes of activation and almost 90% of it are secreted within 1 hour . The a
granules contain various growth factors as described already. Fibrinogen, fibronectin and vitronectin which acts as
cell adhesion molecule in a concentration that of normal blood clot. Additional growth factors are “Insulinlike growth
factor (IGF-I, IGF-II), Fibroblast growth factor(FGF), Endothelial cell growth factor (ECGF), Platelet-Derived
Angiogenesis Factor (PDAF), Osteocalcin (Oc), Osteonectin (On) and Thrombospondin 1(TSP 1). PRP also has
serotonin, histamine, dopamine, calcium and adenosine[54] which causes inflammation and begin the first stage of
healing. Serotonin and histamine increases the capillary permeability and bring the inflammatory cells to wound site
and activate macrophages.
Not only the platelets in the PRP, but even the plasma contributes in healing.On activation fibrinogen and other
clotting factors forms a mesh where cells adhere, migrate and proliferate. The growth factors which was released
earlier attract undifferentiated cells and increases cell division, cytokines in PRP reduces inflammation. They
interact with macrophages and promote tissue healing and angiogenesis. PRP also secrete some antimicrobial
proteins which has antibacterialaction. Miller et al proved that, PRP reduces pain at the site of application

VIABILITY AND SAFETY OF PRP:

Despite the methods used for the activation of platelets or release of growth factors starts within 10 minutes of
initiation of clot, 95 percent of secretion is completed within one hour. Tryptan blue stain helps to know the viability
of platelet concentration in PRP.

PRP is much safer, since it’s an autologous preparation, i.e. prepared from the concerned patient himself. There is
no risk of viral transmission such as hepatitis B or C, HIV, west nile fever and Cruetzfeld-Jacob disease (CJD)
(“mad cow disease”). It lacks nucleus and hence there is no chance of mutagenic effect.
PRP is no different from the blood clot in any wound or graft, therefore cannot yield bacterial growth like any other
blood clot. Moreover, pH of PRP is 6.5 to 6.7 compared with a mature blood clot of 7.0 to 7.2, which actually inhibits
bacterial growth.

HOW MUCH OF PRP IS REQUIRED?

According to Haynesworth et al ,proliferation of adult mesenchymal cells and its differentiation were directly
proportional to platelet concentration, which was explained with a dose response curve, that adequate cellular
response to platelet concentration first began where there was 4 to 5 fold increase in the platelet concentration.
Another study by Lui et al[56], showed increase in proliferation of fibroblasts and type I collagen with increased
platelet concentration. It was also dependent on pH value, as best response was seen in acidic levels (pH 6.5 -6.7 ).

1.33. ADVANTAGES OF PRP USAGE

• PRP can be easily prepared and used in Opd setup.

• It’s unlikely that it causes infection or allergic reaction since it’s purely an autologous preparation.
• Only 5-10ml of blood is required for preparation of PRP.

• The duration for PRP preparation is less.

• Easy to administer, be it in gel like form or with syringe.

 2.REVIEW OF LITERATURE

2.1 Ayman H. Salah Eldin conducted a study on Role of Platelet-Rich Plasma to

Decrease Post Tonsillectomy Pain and Bleeding.In his study he stated that Topical

application of Platelet-Rich Plasma on the tonsillar bed once at the time of

operation improves postoperative pain and recovery in adult patients. 6

2.2 James D. Sidman et al. conducted a study on Platelet-Rich Plasma for

Pediatric Tonsillectomy Patients.In his study he stated Platelet-Rich Plasma

applied once at the time of tonsillectomy does not improve postoperative pain or

recovery in pediatric patients.1

2.3 M NChettri et al. conducted a study on Haemostasis and analgesia with

autologous platelet-rich plasma in tonsillectomy.In his study he stated the pain

score and haemorrhage grade on the test side were lower than on the control side.

These findings were statistically significant.2

2.4 Irakli et al. conducted a study on Evaluation of hemostatic and analgetic effects

of platelet rich plasma in tonsillectomy.In his study he stated Pain scores reached

statistical significance. There appears to be advantage to the use of platelet-rich

plasma in tonsillectomy, but further investigations are necessary.4

2.5 Sinem Gökçe Kütük et al. conducted a study on The impact of platelet-rich

plasma therapy on short-term postoperative outcomes of pediatric tonsillectomy

patients.In his study he stated

superiority of tonsillectomy with PRP over tonsillectomy alone in terms of

effectiveness in reducing post-tonsillectomy pain and improving appetite status,

together with a lower requirement for analgesia and a reduced risk of post-

tonsillectomy bleeding during the first 10 postoperative days.3

2.6 Nanditha s. et al. conducted a randomised control study on Efficacy of

topical application of autologous platelet-rich plasma in adult tonsillectomy

patients.In her study she stated that significant decrease in the mean pain score up

to day 7 (p < 0.05) and tonsillar fossae healing on day 2 and day 3 (p < 0.05) post-

tonsillectomy was noted. The majority of the patients returned to their routine

activities after a week post-tonsillectomy.9

2.7 Hadeer Abd El-moneim Saad et al. conducted a study on Determining

the Impact of Platelet-rich Plasma Therapy on Short-term Postoperative

Outcomes of Pediatric Tonsillectomy Patients in Egypt.In his study he stated

that Platelet-Rich Plasma was beneficial in the amelioration of post-

tonsillectomy pain, improvement of healing and bleeding risk in pediatric

tonsillectomy patients.8
2.8 Semenov FV et al. conducted a study on Usage of platelet-enriched plasma

as hemostatic and analgenic medication in tonsillectomy.In his study he noticed

that Swallowing test and analysis of the visual-analogue scales demonstrated

that pain after tonsillectomy was less severe after local use of PEP. Thus, usage

of PEP in the region of the postoperative wound is effective in prevention of

hemorrhage and pharyngeal pain attenuation after tonsillectomy28.

2.9 M STAVRAKAS et al. conducted a study on Platelet-rich plasma in

otolaryngolog.He stated that Overall, platelet-rich plasma is a promising material

with a number of potential clinical applications. The studies included in this

review confirmed that platelet-rich plasma benefits the healing process, mainly

by promoting growth factor aggregation29

2.10 M KARA et al. conducted a study on Does topical use of autologous

serum help to reduce post-tonsillectomy morbidity? A

prospective, controlled preliminary study.In his study he stated that in

tonsillectomy patients, topically administered autologous serum contributed

to throat pain relief and tonsillar fossa epithelisation during the post-

operative period31
 3.Justification
3.1 Healing & recovery time and reducing pain after tonsillectomy is an

important component of postoperative care.Platelet rich plasma serves as a

growth factor agonist, and has both mitogenic and chemotactic properties.

Platelet rich plasma contains a high level of platelets, and a full complement of

clotting and growth factors.²

3.2 Platelets initiating wound repair by releasing locally acting growth factors via
the degranulation of α-granules.The secretory proteins contained in the α-granules
of platelets include: platelet-derived growth factor, transforming growth factor-β,
platelet factor-4,interleukin-1, plateletderived angiogenesis factor, vascular
endothelial growth factor, epidermal growth factor, epithelial cell growth factor,
insulin-like growth factor, osteocalcin,fibrinogen, vitronectin, fibronectin and
thrombospondin-1. These growth factors attract un-differentiated cells in the
newly formed matrix and by triggering cell division.²
3.3 In this study we are going to determine whether use of topical administration
of autologous platelet rich plasma on Tonsillectomy fossa decreases post operative
pain and enhance healing and recovery time.
So that postoperatively patient will have reduced pain and healing and
recovery time will be faster so there is decrease in need of medication and no delay
in discharge of patient and hospital stay will decrease and patient can soon start
eating normally and patient can return to normal activities earlier.
 4.AIM
4.1 To study the effect on post-operative pain and enhancement of healing and
recovery time following topical application of autologous Platelet-Rich Plasma
(PRP) in the tonsillectomy fossae.
 5.OBJECTIVE
5.1. To investigate the effectiveness of Platelet-rich plasma application in
healing of the tonsillar fossa.

5.2. To assess the effectiveness of Platelet-rich plasma in reducing post-

operative pain.

5.3. To assess the number of days required for the patient to return to normal
activities.
 6.Inclusion criteria
6.1 AGE: 4 -18yrs

6.2 patients undergoing tonsillectomy under general anaesthesia who

gave their consent.
 7.EXCLUSION CRITERIA
7.1 AGE: below 4 yrs and above 18 yrs

7.2 History of dysphagia or odynophagia due to causes other than

tonsillitis.

7.3 Patients suffering from bleeding disorders

7.4 Patients undergoing tonsillectomy for reasons other than chronic

tonsillitis.
 8.Methodology

8.1 STUDY POPULATION : 40 PATIENT'S

8.2 PLACE OF STUDY : Department of ENT

Vinayaka missions medical college,karaikal

8.3 PERIOD OF STUDY : 18 months

8.4 STUDY DESIGN : Prospective study

 Study approved by Ethical Committee

Obtained informed and written consent

from the patient

Inclusion and exclusion criteria applied

and sample selected
 METHODOLOGY

STUDY POPULATION : 40 PATIENT'S

The patients were divided into 2 groups :

GROUP 1 PRP GROUP : 20 patients

GROUP 2 CONTROL GROUP : 20 patients

 GROUP 1 PRP GROUP

autologous platelet-rich plasma freshly prepared was used to layer the tonsillar fossa
immediately after the surgery. Patients were then evaluated for post operative pain
and healing and recovery time on 0 day 1st day, 2nd day ,3rd day and On follow up
on 7thday and 14thday.

GROUP 2 CONTROL GROUP

Post tonsillectomy Patients were then evaluated for post operative pain and
healing and recovery time on 0 day, 1st day ,2nd day, 3rd day and On follow up
on 7thday and 14thday.
Till now in this study we have selected 30 patients out of that 20 cases
PRP group and 10 cases control group.
S.N PATIENT NAME Grading of VAS Grading VAS Grading VAS Grading VAS Grading VAS Grading VAS
o PRP GROUP healing pain of pain of pain of pain of pain of pain
score healing score healing score healing score healing score healing score

DAY 0 DAY 1 DAY 2 DAY 3 DAY 7 DAY 14

1 Mohammed arif 4 7 2 6 1 4 1 3 1 1 1 1

2 Noorul Hamitha 4 8 1 7 1 5 1 3 1 1 1 1

3 Menaga 4 8 3 7 2 5 1 4 1 2 1 1

4 Bifina fathima 4 7 2 6 1 4 1 3 1 1 1 1

5 Hanisha banu 4 8 3 7 2 5 1 4 1 1 1 1

6 Santhosh 4 7 2 5 2 4 1 2 1 1 1 1

7 Varshini 4 7 2 6 2 4 1 2 1 1 1 1

8 Priyadarshan 4 8 3 7 2 5 2 4 1 1 1 1

9 Karthika 4 7 2 6 2 4 1 3 1 1 1 1

10 Kathigeyan 4 7 2 5 1 4 1 2 1 1 1 1
S.No PATIENT Grading of VAS Grading VAS Grading of VAS Grading of VAS Grading VAS Grading VAS
NAME healing pain of healing pain healing pain healing pain of pain of pain
PRP score score score score healing score healing score
GROUP

DAY 0 DAY 1 DAY 2 DAY 3 DAY 7 DAY 14

11 Haritha 4 7 2 6 2 4 1 2 1 1 1 1
shree

12 Subhisha 4 8 4 7 4 4 2 2 1 1 1 1

13 Abirami 3 8 2 7 1 5 1 3 1 1 1 1

14 Sajith 4 9 3 6 2 5 1 3 1 2 1 1

15 Afsal 4 8 2 7 2 5 1 4 1 1 1 1

16 Kaviraj 4 8 2 6 2 4 1 2 1 1 1 1

17 Harish 4 9 4 7 3 5 2 3 1 1 1 1

18 Jabrin khan 4 7 4 6 3 4 1 2 1 1 1 1

19 Mohammed 4 7 4 5 3 4 2 2 1 1 1 1
Afsal

20 Subathra 4 7 4 6 4 4 2 3 1 1 1 1
S.N PATIENT Grading VAS Gradin VAS Grading VAS Grading VAS Grading of VAS Grading VAS
o NAME of healing pain g of pain of pain of healing pain healing pain of pain
CONTROL score healing score healing score score score healing score
GROUP

DAY 0 DAY 1 DAY 2 DAY 3 DAY 7 DAY 14

1 Reyasri 4 9 3 7 2 6 1 4 1 1 1 1

2 Sindhu 4 9 3 8 2 6 1 4 1 1 1 1

3 Santhosh 4 8 3 7 2 6 1 4 1 1 1 1

4 Manjula 4 8 3 7 3 6 2 4 1 1 1 1

5 Ishwarya 4 7 4 6 3 5 2 4 1 1 1 1

6 Gayathri 4 8 4 7 4 6 2 4 2 1 1 1

7 Subhavarshi 4 8 3 7 2 6 1 5 1 2 1 1
ni

8 Ahammed 4 8 3 7 2 5 2 4 2 1 1 1
ariesh

9 Rohith 4 8 3 6 2 6 2 5 1 2 1 1

10 Shivasri 4 8 4 7 3 6 2 4 1 1 1 1
 9.STUDY VARIABLES
To assess the effectiveness of Platelet-rich plasma in reducing post-operative pain using
the visual analogue scale which is a numerical pain scale numbered from 0 to 10.

To investigate the effectiveness of Platelet-rich plasma application in faster healing.

Healing was assessed one week after the tonsillectomy when patient came for review
based upon the percentage of unhealed raw area.

Grade 1 – raw area 25% or less

Grade 2 – 25- 50 %

Grade 3 – 50 -75 %

Grade 4- more than 75%

Number of days required for the patient to return to normal activities.

All these variables were assessed on post-operative day 0-3 and on 1st and 2nd
week of follow up.
ETHICAL COMMITTEE CERTIFICATE
ETHICAL COMMITTEE
CLINICAL TRIAL REGISTRY INDIA (CTRI)
APPROVAL FORM
CTRI
PROFORMA
EFFICACY OF AUTOLOGOUS PLATELET RICH PLASMA IN TONSILLECTOMY

PROFORMA
Name: I.P. No.:
Age: Date of Admission:
Sex: Date of surgery :
Occupation : Date of Discharge :
Address:

CHIEF COMPLAINTS:

RECURRENT THROAT PAIN : Present/Absent Duration -

PAIN ON SWALLOWING : Present/Absent Duration -

DIFFICULTY IN SWALLOWING : Present/Absent Duration-

 HISTORY OF PRESENTING ILLNESS

RECURRENT THROAT PAIN: OTHER COMPLAINTS :

Onset: sudden /insidious FEVER : Present/Absent

progressive/ non –progressive COUGH : Present/Absent

Aggravating factors : Intake of Cold foods / Cold climate BAD BREATH : Present/Absent

Relieving factors : Rest / Medication EARACHE : Present/Absent

PAIN ON SWALLOWING: EAR BLOCK : Present/Absent

Onset: sudden /insidious HEADACHE : Present/Absent

progressive/ non –progressive SNORING : Present/Absent

Aggravating factors :Intake of Cold foods / Cold climate DIFFICULTY ON BREATHING : Present/Absent

Relieving factors :Rest / Medication CHANGE IN VOICE : Present/Absent

DIFFICULTY IN SWALLOWING:

Onset: sudden /insidious

progressive/ non –progressive

Aggravating factors :Intake of Cold foods / Cold climate

Relieving factors :Rest / Medication

 PAST HISTORY:

Previous medical history : Nil/DM / HTN / BA / CAD / Epilepsy / Thyroid Disorders

Previous history of surgery : Yes / No

History of similar complaints in the past : Yes / No

History of any drug allergy : Yes / No

PERSONAL HISTORY:

Food habits: Mixed / Veg

Sleep and appitite : Normal / Abnormal

Bowel and bladder habits : Normal / Abnormal

Addictions : Yes / No

MENSTURAL HISTORY:

Last menstrual period :

Menstrual cycle : Regular / Irregular

Menstrual blood flow : Normal / Abnormal

Not applicable

FAMILY HISTORY:
 GENERAL EXAMINATION:
Patient is well /moderately/ poorly and well/moderately/poorly Nourished

Patient is conscious / unconscious and oriented / disoriented to time,place, person

Pallor : Yes / No

Icterus :Yes / No

Cyanosis :Yes / No

Clubbing :Yes / No

Generalized Lymphadenopathy :Yes / No

Pedal edema :Yes / No

Vital Data:

Pulse :______Beats per minute

Blood pressure :_________mmHg

Temperature :________°F

Respiratory rate :_________cycles per minute

SYSTEMIC EXAMINATION:

Central nervous system: No focal neurological defecit / Abnormal

Cardiovascular system: S1 S2 heard & no murmur / Abnormal

Respiratory system: Normal vesicular breath sounds & no added sounds / Abnormal
 ENT EXAMINATION

Oral cavity and Oropharynx: Soft palate : Normal / Abnormal

Lips: Normal / Abnormal Anterior pillar: Normal / Congested

Gums: Normal / Abnormal Tonsil: Normal / congested

Teeth: Normal / Abnormal Hypertrophy / Atrophy

Tongue: Normal / Abnormal Right/ Left / Bilateral Tonsillar hypertrophy

Buccal mucosa: Normal / Abnormal Grading of hypertrophy :

Gingivobuccal sulcus : Normal / Abnormal Grade 1 / Grade 2 / Grade 3 / Grade 4

Gingivolabial sulcus : Normal / Abnormal Membrane over tonsil : present / not present

Retro molar trigone: Normal / Abnormal Follicles in tonsil crypts : present / not present

hard palate: Normal / Abnormal Irwin moore sign : positive / Negative

Posterior pillar: Normal / Congested / Not visible

Posterior pharyngeal wall: Normal / Congested

Uvula: Normal / Abnormal

Neck examination: Jugulo digastric lymph nodes : Not palpable / palpable : Right/ Left / bilateral , Size -

soft/firm/hard, Tender / Non tender,Mobile / Fixed

Ear: Right Left

Pre-auricular area

Pinna

Post-auricular area

External auditory canal

Tympanic membrane

Facial nerve

Nose:

a) External framework : Normal / Abnormal

b) Anterior rhinoscopy : Normal / Abnormal

Diagnosis :
 INVESTIGATIONS:
Hemoglobin____ gm% RFT :

RBC_________________ million cells per microlitre Blood Urea_______ mg/dl

Total WBC Count_______________ cells/cubic millimeter Serum Creatinine______ mg/dl

Differential count : Blood group and typing :_______

N_____% , E______%L_____%, M____%, B____% BT :______min______sec

ESR : _____mm/ ½ hr , ____mm/1 hr CT: ______min______sec

Platelets________Lakh per microlite Urine: Albumin_____ Sugar_____ME ________________

HIV _______ HBsAg ______ Chest XRAY ________

RBS _______mg/dl ECG________

COVID RT-PCR TEST___________

PROCEDURE : PLATELET RICH PLASMA IN TONSILLAR FOSSA DURING TONSILLECTOMY :

Applied / Not Applied

Follow up results:
 Day 0 Day 1 Day 2 Day 3 1 week 2 week
Pain:

VAS
Grading of Healing
No. of days to return to normal
activities
CONSENT FORMS
 VINAYAKA MISSION’S MEDICAL COLLEGE
DEPARTMENT OF ENT
Efficacy of autologous platelet rich plasma in tonsillectomy
PATIENT INFORMATION AND CONSENT FORM
Patient’s Name : ____________________________________________
Age and sex : _____________________________________________
IP NO / OP NO : _____________________________________________
 
Dr. _______________________________________has fully explained to me the nature and purpose of the platelet rich plasma application in
tonsillectomy fossa in which my child have been asked to participate. I have completely understood the details of the study.

The medical records that are related to this study will be maintained confidentially. The results of this study may help to improve further the treatment
strategies .

I understand that I can withdraw from the study at any point of time and even then, I will continue to receive the medical treatment as usual.
I know what I am supposed to do by taking part in this study and I assure that I would extend my full co-operation for this study.
I confirm that I have been told about this study in my mother tongue. I have been given the opportunity to ask questions concerning the study.
I freely agree to participate in this study.
 
Father/mother /guardian signature : __________________________ Date and Time : ______
Name in block letters : ___________________________
Witness signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
Doctor’s signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
 VINAYAKA MISSIONS MEDICAL COLLEGE & HOSPITAL KARAIKAL
Efficacy of autologous platelet rich plasma in tonsillectomy
PROCEDURE CONSENT FORM
 
Mr/Mrs .___________________________ Age_____Sex_____,
I hereby voluntarily give my consent to undergo the study of “Efficacy of autologous
platelet rich plasma in tonsillectomy” as control group in which my child has been asked to
participate.I have been explained the nature, risk and benefits of the procedure by the
physician. I will not hold the physician/Hospital/Hospital workers for any adverse events
that might happen during the procedure.
 
Father/mother/guardian signature : _________________ Date and Time :
______
Name in block letters : ___________________________

Witness signature : ___________________________ Date and Time : ______

Name in block letters : ___________________________
 
 Doctor’s signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
 VINAYAKA MISSION’S MEDICAL COLLEGE, KARAIKAL
DEPARTMENT OF ENT
Efficacy of autologous platelet rich plasma in tonsillectomy
REVERSE TRANSLATION
Patient’s Name : __________________________
Age and sex : ___________________________
IP NO/OP NO : __________________________
 
Doctor ________________has explained about the participation of my child in this study. Doctor has also
explained about the aim of the study “Efficacy of autologous platelet rich plasma in tonsillectomy” in which my
child have been asked to participate as control group. This study has been explained to me in detail. Details
regarding this study will be confidentially maintained. The results of this study might help to improve the
quality of treatment in future. I have every right to withdraw myself from the study at any time. I confirm that
I have been told about this study in my mother tongue and hereby I accept wholeheartedly to join this study.
 
Father/mother/ guardian signature : __________________________ Date and Time : ______
Name in block letters : ___________________________
 
Witness signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
 
 Doctor’s signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
 விநாயகமிஷன்ஸ்மருத்துவக்கல்லூரிமருத்துவமனை,காரைக்கால
்
ஒப்புதல்படிவம்
நோயாளியின்பெயர்:_________________________________________________

பெற்றோர்பெயர் :_________________________________________________

உ.நோ-வெ.நோஎண்: _________________________________________________

 "டான்சிலெக்டோமியில் தன்னியக்க பிளேட்லெட் நிறைந்த பிளாஸ்மாவின் செயல்திறன்" என்ற ஆய்வின் தன்மை மற்றும் நோக்கத்தை மருத்துவர் எனக்கு முழுமையாக
விளக்கியுள்ளார், இதில் எனது குழந்தை கட்டுப்பாட்டுக் குழுவாக பங்கேற்கும்படி கேட்டுக் கொள்ளப்பட்டது. படிப்பின் விவரங்களை முழுமையாக புரிந்து
கொண்டேன். பரிசோதனை விவரங்களை முழுமையாக புரிந்து கொண்டேன்.
இந்த ஆய்வு தொடர்பான மருத்துவ பதிவுகள் ரகசியமாக பராமரிக்கப்படும். இந்த ஆய்வின் முடிவுகள், சி கிச்
ச ைஉத்
திகள ை
மேலும் மேம்படுத்த உதவக்கூடும்.நான் எந்த நேரத்திலும் பரிசோதனை இருந்து விலக முடியும் என்பதையும்
புரிந்துகொள்கிறேன்.இந்த ஆய்வில் பங்கேற்பதன் மூலம் நான் என்ன செய்ய வேண்டும் என்பதை நான் அறிவேன், மேலும் இந்த ஆய்வுக்கு எனது முழு
ஒத்துழைப்பையும் வழங்குவேன் என்று உறுதியளிக்கிறேன். இந்த ஆய்வு குறித்து எனது தாய்மொழியில் கூறப்பட்டுள்ளதை உறுதி செய்கிறேன்.
படிப்பு தொடர்பான கேள்விகளைக் கேட்க எனக்கு வாய்ப்பு அளிக்கப்பட்டுள்ளது.இந்த ஆய்வில் பங்கேற்க நான் சுதந்திரமாக
ஒப்புக்கொள்கிறேன்  

்தாய் / தந்தை / பாதுகாவலர் கையொப்பம்

்: _______________________ தேதி/நேரம்: _______________
நோயாளியின்பெயர்: ___________________________
சாட்சிகையொப்பம்: ___________________________ தேதி/நேரம்: ______________
சாட்சிபெயர்: ___________________________________
மருத்துவர்கையொப்பம்: _________________________தேதி/நேரம்: _______________
மருத்துவர்பெயர்: _________________________
 VINAYAKA MISSION’S MEDICAL COLLEGE
DEPARTMENT OF ENT
Efficacy of autologous platelet rich plasma in tonsillectomy patients
PATIENT INFORMATION AND CONSENT FORM
Patient’s Name : ____________________________________________
Age and sex : _____________________________________________
IP NO / OP NO : _____________________________________________
 

Dr. _______________________________________has fully explained to me the nature and purpose of the platelet rich
plasma application in tonsillectomy fossa in which my child have been asked to participate. I have completely understood the details of the study.

The medical records that are related to this study will be maintained in confidence. The results of this study may help to improve further the
treatment strategies .

I understand that I can withdraw from the study at any point of time and even then, I will continue to receive the medical treatment as usual.
I know what I am supposed to do by taking part in this study and I assure that I would extend my full co-operation for this study.
I confirm that I have been told about this study in my mother tongue. I have been given the opportunity to ask questions concerning the study.
I freely agree to participate in this study.
 
Father/mother /guardian signature : __________________________ Date and Time : ______
Name in block letters : ___________________________
Witness signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
Doctor’s signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
 VINAYAKA MISSIONS MEDICAL COLLEGE & HOSPITAL KARAIKAL
Efficacy of autologous platelet rich plasma in tonsillectomy patients
PROCEDURE CONSENT FORM
Mr/Mrs .___________________________ Age_____Sex_____,
I hereby voluntarily give my consent to undergo the platelet rich plasma application in
tonsillectomy fossae in which my child has been asked to participate.I have been explained
the nature, risk and benefits of the procedure by the physician. I will not hold the
physician/Hospital/Hospital workers for any adverse events that might happen during the
procedure.
 
Father/mother/guardian signature : _________________ Date and Time :
______
Name in block letters : ___________________________

Witness signature : ___________________________ Date and Time : ______

Name in block letters : ___________________________
 
 Doctor’s signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
 VINAYAKA MISSION’S MEDICAL COLLEGE, KARAIKAL
Efficacy of autologous platelet rich plasma in tonsillectomy patients
DEPARTMENT OF ENT

REVERSE TRANSLATION
Patient’s Name : __________________________
Age and sex : ___________________________
IP NO/OP NO : __________________________
 
Doctor ________________has explained about the participation of my child in this study. Doctor has also explained
about the aim of the study and importance of using platelet rich plasma application in tonsillectomy fossae in
which my child have been asked to participate. This study has been explained to me in detail. Details regarding this
study will be confidentially maintained. The results of this study might help to improve the quality of treatment in
future. I have every right to withdraw myself from the study at any time. I confirm that I have been told about this
study in my mother tongue and hereby I accept wholeheartedly to join this study.
 
Father/mother/ guardian signature : __________________________ Date and Time : ______
Name in block letters : ___________________________
 
Witness signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
 
 Doctor’s signature : ___________________________ Date and Time : ______
Name in block letters : ___________________________
 விநாயகமிஷன்ஸ்மருத்துவக்கல்லூரிமருத்துவமனை,காரைக்கால்
ஒப்புதல்படிவம்
நோயாளியின்பெயர்:_________________________________________________

பெற்றோர்பெயர் :_________________________________________________

உ.நோ-வெ.நோஎண்: _________________________________________________

டான்சிலெக்டோமி ஃபோசேயில் பிளேட்லெட் நிறைந்த பிளாஸ்மா அப்ளிகேஷனை மேற்கொள்ள நான் முன்வந்து ஒப்புதல்

அளிக்கிறேன். அதில் எனது குழந்தை பங்கேற்கும்படி கேட்டுக் கொள்ளப்பட்டுள்ளது. இந்த செயல்முறையின் தன்மை, ஆபத்து மற்றும்

நன்மைகள் குறித்து மருத்துவரால் எனக்கு விளக்கப்பட்டுள்ளது.டான்சிலெக்டோமி ஃபோசேயில் பிளேட்லெட

நிறைந்த பிளாஸ்மாபயன்பாட்டைப் பயன்படுத்துவதன் முக்கியத்துவம் மற்றும் ஆய்வின் நோக்கம் குறித்தும்

மருத்துவர் விளக்கியுள்ளார்.

இந்த ஆய்வு தொடர்பான மருத்துவ பதிவுகள் ரகசியமாக பராமரிக்கப்படும். இந்த ஆய்வின் முடிவுகள், சி
கிச்
ச ைஉத்
திகள ை
மேலும் மேம்படுத்த உதவக்கூடும்.நான் எந்த நேரத்திலும் பரிசோதனை இருந்து விலக முடியும் என்பதையும் புரிந்துகொள்கிறேன்.இந்த ஆய்வில் பங்கேற்பதன் மூலம் நான் என்ன
செய்ய வேண்டும் என்பதை நான் அறிவேன், மேலும் இந்த ஆய்வுக்கு எனது முழு ஒத்துழைப்பையும் வழங்குவேன் என்று உறுதியளிக்கிறேன். இந்
த ஆ ய்
வுக ு
றித்
து
எனது தாய்மொழியில் கூறப்பட்டுள்ளதை உறுதி செய்கிறேன். ஆய்வு தொடர்பான கேள்விகளைக் கேட்க எனக்கு வாய்ப்பு
அளிக்கப்பட்டுள்ளது. இந்தகையொப்
தாய் / தந்தை / பாதுகாவலர் ஆய்வில் பபங்
ம் கேற்க நான் சுதந்திரமாக ஒப்புக்கொள்கிறேன்
்:
் _______________________ தேதி/நேரம்: _______________
நோயாளியின்பெயர்: ___________________________
சாட்சிகையொப்பம்: ___________________________ தேதி/நேரம்: ______________
சாட்சிபெயர்: ___________________________________
மருத்துவர்கையொப்பம்: _________________________தேதி/நேரம்: _______________
மருத்துவர்பெயர்: _________________________
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