Professional Documents
Culture Documents
Ministry of Health
(CAPA-MOHP)
الاصدار السابع
This Issue No.7, Antibiotic Use For Surgical Prophylaxis Protocol includes a guidance for the appropriate
use of antibiotics in surgical prophylaxis addressing general principles for prescribing, procedure, and
national guidelines for adults and pediatrics. For the aim of improving patients’ outcomes and minimizing
the unnecessary use of antibiotics in surgical prophylaxis, and thus subsequent resistance.
Acknowledgment
Editor-in-Chief
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Editorial Board
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
ANTIBIOTIC USE FOR SURGICAL PROPHYLAXIS
Items of content
1. Introduction
2. Objectives
3. Pre-operative considerations
4. General principles of surgical prophylaxis
5. Surgical wound classification
6. Preoperative dose timing
7. Duration of antibiotics
8. Allergy to Beta-lactam antimicrobials
9. Patients receiving therapeutic antimicrobial for active Infection before Surgery
10. Responsible team
11. Procedures
12. Antibiotic use for surgical prophylaxis guideline in adults
13. Antibiotic use for Surgical prophylaxis guideline in pediatrics
14. References
Introduction
Surgical antibiotic prophylaxis is defined as the use of antibiotics to prevent infections at the surgical site. This term
is used to describe antimicrobial therapy prescribed to clear infection by an organism or to clear an organism
colonized but not causing infection.
The use of preoperative antimicrobials has become an essential component of the standard of care for certain
surgical procedures and can result in a reduced risk of post-operative infection when appropriately prescribed.
However, the benefit of antimicrobial prophylaxis must be weighed against the risks of toxic and allergic reactions,
emergence of resistant bacteria, drug interactions, super-infection, and cost.
This Surgical Antimicrobial Prophylaxis Prescribing Protocol has been developed to assist clinicians with
recommendations on appropriate antimicrobial selection, dosing, timing and duration for a range of surgical
procedures.
Objectives
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Pre-operative considerations
• Type and site of surgical procedure should be considered for selecting of the appropriate antibiotic that
provides coverage of the expected microbiological flora at the incision site.
• Individual healthcare institutions should consider local resistance patterns of organisms when adopting these
recommendations, the choice of the antimicrobial agent should take into account the local resistance
patterns
• The choice of antimicrobial is further influenced by multiple patient-specific risk factors including:
➢ Pre - existing infection
➢ Recent antimicrobial use
➢ Known colonization with a resistant organism
➢ Prolonged hospitalization
➢ Prostheses
➢ Weight
➢ Renal function
➢ Allergy status
➢ Comorbidities
➢ Immunosuppression
• Prevention of surgical site infections are based on a combination of perioperative antibiotic prophylaxis with
other measures as preoperative preparation, surgical techniques, and postoperative wound care
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Surgical Wound Classification
Surgical wounds are classified according to National Healthcare Safety Network (NHSN) into the following:
• Clean: An uninfected operative wound in which no inflammation is encountered and the respiratory,
alimentary, genital, or uninfected urinary tract is not entered. In addition, clean wounds are primarily closed
and, if necessary, drained with closed drainage.
• Clean-Contaminated: An operative wound in which the respiratory, alimentary, genital, or urinary tracts are
entered under controlled conditions and without unusual contamination. Specifically, operations involving
the biliary tract, appendix, vagina, and oropharynx are included in this category, provided no evidence of
infection or major break in technique is encountered.
• Contaminated: Open, fresh, accidental wounds. In addition, operations with major breaks in sterile technique
(ex, open cardiac massage) or gross spillage from the gastrointestinal tract, and incisions in which acute, non-
purulent inflammation is encountered are included in this category.
• Dirty or Infected: Old traumatic wounds with retained devitalized tissue and those that involve existing
clinical infection or perforated viscera. This definition suggests that the organisms causing postoperative
infection were present in the operative field before the operation.
Repeat Dosing
Single dose should only be given unless otherwise indicated. Redosing in the operation room may be required in
some cases as for antibiotics with short half-life as Cefazolin or cefoxitin in extended procedures in which the
procedure duration exceeds the recommended redosing interval (from the time of initiation of the preoperative
dose). Also, in case of extensive or prolonged bleeding and other factors that may shorten half-life of the
prophylactic antimicrobial used as in extensive e burns.
In clean and clean-contaminated procedures, do not administer additional prophylactic antimicrobial agent doses
after the surgical incision is closed in the operating room, even in the presence of a drain and the same applied to
prosthetic joint arthroplasty.
Duration of Antibiotics
If post-operative dose of antibiotic is required, the duration should be less than 24 hours for most procedures. Some
cardiothoracic procedures require prophylaxis duration of up to 48 hours.
Route of Administration
Parenteral administration (intravenous or intramuscular) is the preferred route for surgical antimicrobial prophylaxis.
Topical prophylaxis is currently not indicated for most wounds, especially those resulting from clean procedures.
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
reactions, vancomycin is considered as acceptable alternative. Cephalosporins and carbapenems can safely be used
in patients with an allergic reaction to penicillins that is not an IgE mediated reaction (e.g., anaphylaxis, urticaria,
bronchospasm) or exfoliative dermatitis (Stevens-Johnson syndrome, toxic epidermal necrolysis). Patients should be
carefully questioned about their history of antimicrobial allergies to determine whether a true allergy exists before
selection of agents for prophylaxis as misdiagnosis with true allergy leads to recommendations for alternative
antimicrobial therapy with the potential of increased costs, and adverse events.
Responsible team
Complying with antibiotic prophylaxis use protocol in surgical procedures requires the coordination of health care
stuff in the hospital. This includes but is not limited to the entire operating room and perioperative staff members
and other health care members including:
• Heads of surgical departments and the surgeons
• Anesthesiologists
• Head of Pharmacists
• Clinical pharmacy team
• Nursing stuff (preoperative – based nursing stuff)
• Infection prevention and Control head
• Quality control head
• Pharmaceutical Supply department
• Drug Information Center team
Procedures
• The protocol is developed according to the guidelines stated below for the surgical procedures performed in
the hospital.
• The protocol is then discussed in the pharmacy and therapeutics committee, with the participation of the
heads of surgical departments, anesthesiologists, infection prevention and control head and quality control
head then approve the protocol.
• The head of pharmacy ensures that the selected prophylactic antibiotics for prophylaxis are available in the
hospital through coordinating with the supply chain.
• The responsible team publishes and distributes the protocol to all surgical operations departments in the
hospital.
• Education regarding the protocol to be provided to surgeons, anesthesiologists, residents and nursing
personnel before and during the implementation of the protocol.
• The clinical pharmacy team reviews daily patients taking antibiotics for surgical prophylaxis to ensure
compliance with local guidelines and ensure that antimicrobials taken post-operatively are stopped within 24
hours.
• Periodical review audits should be done to measure the adherence to the protocol through setting suitable
process indicators for data. This can be supported through coordination with patient safety and quality team,
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
and infection prevention and control team with highlighting the responsibilities of team members performing
the audit. These reviews have to be presented and discussed in the antimicrobial stewardship committee or
drug and therapeutics committee to take action to improve nonadherent practice.
Antibiotic audit tools and record forms have been developed to assess the usage of antibiotics in surgical
prophylaxis and the adherence with the policy (regarding the choice of agent, timing of preoperative dose
and duration of post-operative prophylaxis). Useful examples to refer to:
I. https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-
safety/hais/tools/surgery/tools/surgical-complication-prevention/antibiotic_audit.docx
II. https://linkinghub.elsevier.com/retrieve/pii/S0929-6646(08)60139-4
• Tracking the consumption of antibiotics used in surgical prophylaxis through DDD can be helpful as a simple
indicator to reflect the compliance with the policy.
• The responsible team updates and reviews the protocol when needed.
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Recommended dosing and redosing interval for Antimicrobials in Surgical Prophylaxis mentioned in the Guidelines
below
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Antibiotic Use in Surgical Prophylaxis Guideline - Adults
Surgery Common pathogen Recommended Dosage regimen after surgery
Antibiotics
Thoracic surgeries
Thoracic (noncardiac procedures): Staphylococcus Cefazolin 2 g/ 8hrs up to 2 doses
lobectomy, pneumonectomy, lung aureus,
resection, thoracotomy Staphylococcus OR Ampicillin-sulbactam 3g/6hrs up to 3 doses
epidermidis, (Alternative if cefazolin unavailable)
streptococci, enteric OR vancomycin
gram-negative bacilli (If allergic to penicillin or cephalosporins, or
risk of MRSA colonization)
OR clindamycin 900 mg/8h up to 2 doses
(Alternative to vancomycin)
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
pacemaker implantation), Staphylococcus (If allergic to penicillin or cephalosporins, or
placement of ventricular assist epidermidis risk of Methicillin-resistant Staphylococcus
devices aureus (MRSA) colonization)
OR Clindamycin
(Alternative to vancomycin)
Gastroduodenal surgery
•Procedures involving entry into Enteric gram- negative Cefazolin 2 g/ 8hrs up to 2 doses
lumen of gastrointestinal (GI) tract bacilli, gram-positive
•Procedures not involving entry cocci
into lumen of GI tract (selective OR Vancomycin + Gentamicin
vagotomy, anti-reflux). High risk (If allergic to penicillin or cephalosporins, or
only: (Severe obesity, (GI) risk of MRSA colonization)
obstruction, decreased gastric
acidity or GI motility, gastric
bleeding, malignancy or OR Clindamycin + Gentamicin (Reasonable
perforation, or alternative for patients allergic to penicillins
immunosuppression. and cephalosporins)
Biliary tract surgery (including pancreatic procedures)
Open procedure or laparoscopic Enteric gram- negative Cefazolin 2 g/ 8hrs up to 2 doses
procedure bacilli, enterococci, OR Ampicillin-Sulbactam 3g/ 6hrs up to 3 doses
clostridia (If cefazolin unavailable)
For high risk (including age>70 OR Vancomycin + Gentamicin
years, pregnancy, acute (If allergic to penicillin or cephalosporins, or
cholecystitis, nonfunctioning risk of MRSA colonization)
gallbladder, obstructive jaundice, OR Clindamycin + Gentamicin (Reasonable
common bile duct stones, alternative for patients allergic to penicillins
immunosuppression) and cephalosporins)
Laparoscopic procedure (low risk) None None
Appendectomy
Cefazolin + metronidazole 2 g/ 8hrs up to 2 doses
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Enteric gram- negative OR Clindamycin + Gentamicin
bacilli, anaerobes, (Reasonable alternative for patients allergic
enterococci to penicillins and cephalosporins)
OR Metronidazole + Gentamicin, N/A
(Reasonable alternative for patients allergic
to penicillins and cephalosporins)
Small intestine surgery
Non-obstructed Enteric gram- Cefazolin 2 g/8hrs up to 2 doses
negative bacilli, OR Clindamycin + Gentamicin
gram-positive cocci (Reasonable alternative for patients allergic
to penicillins and cephalosporins)
Obstructed Enteric gram- Cefazolin + metronidazole (preferred) 2 g/8hrs up to 2 doses
negative bacilli, OR Metronidazole + Gentamicin
anaerobes, (Reasonable alternative for patients allergic
enterococci to penicillins and cephalosporins)
Hernia repair
Aerobic gram- Cefazolin 2 g/8hrs up to 2 doses
positive organisms
OR Clindamycin
(reasonable alternative for patients allergic
to penicillins and cephalosporins)
OR Vancomycin
(reasonable alternative for patients allergic
to penicillins and cephalosporins
Colorectal surgery
Enteric gram- Parenteral
negative bacilli, Cefazolin + metronidazole (preferred) 2 g/8hrs up to 2 doses
anaerobes, OR ampicillin-sulbactam
enterococci (If Cefazolin unavailable)
OR Clindamycin + Gentamicin (Reasonable
alternative for patients allergic to penicillins
and cephalosporins)
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
OR Metronidazole + Gentamicin (reasonable
alternative for patients allergic to penicillins
and cephalosporins)
Oral (used in conjunction with mechanical bowel preparation):
Neomycin PLUS erythromycin base or metronidazole: Adult dose: In addition to
mechanical bowel preparation: neomycin (1 g) plus erythromycin base (1 g) OR
neomycin (1 g) plus metronidazole (1 g). The oral regimen should be given as 3 doses
over approximately 10 hours the afternoon and evening before the operation.
Genitourinary Procedures
Diagnostic procedures: Enteric gram- Ciprofloxacin None
•Cystoscopy or Ureteroscopy for negative bacilli,
OR Trimethoprim-Sulfamethoxazole
high risk patients enterococci
• Cystoscopy with manipulation
(e.g. Transrectal prostate biopsy) or
upper tract instrumentation (e.g.
Ureteroscopy, shock wave
lithotripsy)
Open/laparoscopic surgery - Clean Enteric gram- Cefazolin
with or without entry to urinary negative bacilli, OR Vancomycin or Clindamycin
tract enterococci (For patients allergic to penicillin and
cephalosporins)
Open/laparoscopic surgery Enteric gram- Cefazolin + Gentamicin
involving implanted prostheses negative bacilli,
OR Vancomycin+ Gentamicin
enterococci
or Clindamycin + Gentamicin
(For patients allergic to penicillin and
cephalosporins)
Open/laparoscopic surgery: Clean- Enterobacteriaceae Cefazolin + Metronidazole
contaminated Enterococci OR Clindamycin
Staphylococci (For patients allergic to penicillin and
cephalosporins)
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Orthopedic procedures
Clean operation involving hand, None
knee, or foot with no implant of
foreign material
Spinal procedures Staphylococcus Cefazolin - Open fractures type I or II: use
Hip fracture aureus, Vancomycin antibiotics for 24 hours
Internal fixation Staphylococcus (If allergic to penicillin or cephalosporins, or - Open fractures type III
Total joint replacement epidermidis risk of MRSA colonization) If no gross contamination: use
Removal of orthopedic hardware antibiotics for 24 hours or 48 hours after
used for treatment of lower Clindamycin wound closure. If contaminated, use for
extremity fracture (Alternative to vancomycin) 48 hours after wound closure
Neurosurgery
Elective craniotomy Staphylococcus Cefazolin Limit post-surgical antibiotic
aureus, S. epidermidis Vancomycin prophylaxis duration to 24 hours
Cerebrospinal fluid shunting (If allergic to penicillin or cephalosporins,
procedures or risk of MRSA colonization)
Clindamycin
Implantation of intrathecal pumps (Alternative to vancomycin)
Head and neck surgery
Clean None None None
Clean with placement of prosthesis Staphylococcus Cefazolin (preferred)
(excludes tympanostomy tube aureus, Epidermidisa, Vancomycin
placement) streptococci (If allergic to penicillin or cephalosporins,
MRSA colonization or MRSA infections
predominant post-operative)
Clindamycin (can be used as an alternative
to vancomycin)
Clean-contaminated Anaerobes Cefazolin + Metronidazole (preferred) Limit doses to 24- 48 hours after
Enteric gram-negative surgery
Bacilli Ampicillin sulbactam
S. aureus (If Cefazolin unavailable)
Clindamycin
Alternative in patients allergic to penicillins
or cephalosporins.
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Breast surgery
Reduction mammoplasty, None
Mammoplasty, Lumpectomy
Prophylactic mastectomy
Breast cancer procedures (e.g., Staphylococcus Cefazolin 2g/8hrs up to 2 doses
axillary node dissection, aureus, OR vancomycin (If allergic to penicillin or
mastectomy for known breast Staphylococcus, cephalosporins, risk of MRSA colonization)
cancer) epidermidis,
streptococci OR clindamycin (alternative to vancomycin)
Gynecological Procedures
Procedure Preferred Regimen Alternative regimen
Hysterectomy, Pelvic reconstruction procedures, including colporrhaphy or Cefazolin Clindamycin PLUS Gentamicin: (if obese
those involving mesh or vaginal sling placement or over-weight based on adjusted body
weight)
Cesarean delivery Cefazolin Clindamycin: mg IV PLUS Gentamicin: (if
(Intact membranes, not in labor) obese or over-weight based on adjusted
body weight)
Cesarean delivery (in labor, ruptured membrane) Cefazolin PLUS Clindamycin IV PLUS Gentamicin: (if
Azithromycin obese or over-weight based on adjusted
body weight) PLUS Azithromycin: 500 mg
IV
Uterine evacuation (Including surgical abortion, suction, dilation and Doxycycline
curettage (D & C), and dilation and evacuation (D&E)
Laparotomy without entry into bowel or vagina Cefazolin
Hysterosalpingogram Not recommended
Laparoscopy (Diagnostic, tubal sterilization, operative except for
hysterectomy)
Other transcervical procedures: Cystoscopy, Hysteroscopy (Diagnostic or
operative) Intrauterine device insertion, Endometrial biopsy, Oocyte
retrieval, D & C for nonpregnancy indication, Cervical tissue biopsy
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Solid Organ Transplantation
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Antibiotic Use for Surgical Prophylaxis Guideline – Pediatrics
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
Procedure Site Antibiotic recommended Alternative
CAPA, MOHP: Issue No.7, (Antibiotic Use for Surgical Prophylaxis) July.2023
إصدار اللجنة العليا لجودة الرعاية
الصيدلية واالستخدام الرشيد للدواء