The Journal of Maternal-Fetal & Neonatal Medicine

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Chlorhexidine–alcohol versus povidone–iodine for

skin preparation before elective cesarean section:
a prospective observational study

Elsayed Elshamy, Yahya Z. A. Ali, Mohammed Khalafallah & Ayman Soliman

To cite this article: Elsayed Elshamy, Yahya Z. A. Ali, Mohammed Khalafallah & Ayman Soliman
(2018): Chlorhexidine–alcohol versus povidone–iodine for skin preparation before elective cesarean
section: a prospective observational study, The Journal of Maternal-Fetal & Neonatal Medicine,
DOI: 10.1080/14767058.2018.1489533

To link to this article: https://doi.org/10.1080/14767058.2018.1489533

Published online: 18 Jul 2018.

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THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE
https://doi.org/10.1080/14767058.2018.1489533

ORIGINAL ARTICLE

Chlorhexidine–alcohol versus povidone–iodine for skin preparation before

elective cesarean section: a prospective observational study
Elsayed Elshamya,b, Yahya Z. A. Alib,c, Mohammed Khalafallaha,d and Ayman Solimana
a
Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Menoufia, Egypt; bDepartment of Obstetrics
and Gynecology, King Abdul-Aziz Airbase Hospital, Dhahran, Saudi Arabia; cDepartment of Obstetrics and Gynecology,
Faculty of Medicine, Fayoum University, Fayoum, Egypt; dDepartment of Obstetrics and Gynecology, Maternity Hospital,
Sabah, Kuwait

ABSTRACT ARTICLE HISTORY

Introduction: The ideal antiseptic agent for skin preparation before elective cesarean section Received 24 April 2018
(CS) is not yet determined. The aim of the study was to assess the impact of skin preparation Revised 11 June 2018
by chlorhexidine–alcohol compared with povidone–iodine before elective CS on the rate of Accepted 12 June 2018
surgical site infection (SSI).
KEYWORDS
Materials and methods: This prospective observational study included a total of 1424 pregnant Cesarean section;
women at term who were candidates for the elective CS and were divided into two equal chlorhexidine–alcohol; povi-
groups of 712 patients in each, group 1 (chlorhexidine–alcohol group) and group 2 (povido- done–iodine; skin
ne–iodine group). Patients were followed up at 1 week and 1 month postoperative to determine preparation; surgical
the rate of SSI. site infection
Results: The rate of SSI was 3.7% (26 patients) in the chlorhexidine–alcohol group compared with
4.6% (33 patients) in the povidone–iodine group (odds ratio: 0.7798, 95% CI: 0.46–1.3, p ¼ .35),
nine patients in the chlorhexidine–alcohol group, and 10 patients in the povidone–iodine group
required resuturing (odds ratio: 0.9, 95% CI: 0.36–2.2, p ¼ .82). Four patients (0.56%) in the
chlorhexidine–alcohol group and five patients (0.7%) in the povidone–iodine group developed
endometritis (p ¼ .74). The rate or readmission because of SSI was 2.7% (19 patients) in the
chlorhexidine–alcohol group and 2.9% (21 patients) in the povidone–iodine group (p ¼ .75).
Conclusions: Skin preparation with either chlorhexidine–alcohol or povidone–iodine resulted in
comparable rates of SSIs. Accordingly, both are suitable antiseptic agents for skin preparation
before elective CS.

Introduction chlorhexidine–alcohol being superior to povidone–

Cesarean section (CS) is the most common operation
performed for women with steadily rising rates all over
the world, which accounts for 32% of all deliveries in
the USA [1].
Skin preparation by antiseptic solution, traditionally
done by povidone–iodine, before CS is paramount for
prevention of surgical site infection (SSI) including
wound infection and/or endometritis [2].
Chlorhexidine–alcohol has been extensively studied
over the past few years, having a higher affinity for
skin binding, higher antibacterial activity, and not
affected by body fluids with more prolonged residual
effects but, it is more expensive and has been associ-
ated to allergic reactions [3].
Previous studies have conflicting results
regarding the effectiveness of skin antiseptics with
iodine with less SSI [4,5] or comparable with
povidone–iodine [6].
The aim of this study was to assess the impact of
skin preparation by chlorhexidine–alcohol compared
with povidone–iodine before the elective CS on the
rate of SSI.
Materials and methods
This prospective observational study was conducted at
the department of obstetrics and gynecology, King
Abdul-Aziz Airbase Hospital, Dhahran, Saudi Arabia in
the period between the beginning of May 2015 and
the end of December 2017.
The institutional review board and ethical commit-
tee formally reviewed and approved the study proto-
col in accordance with the 1964 Helsinki declaration

CONTACT Elsayed Elshamy s_shamy77@yahoo.com Department of Obstetrics and Gynecology, King Abdul-Aziz Airbase Hospital, 041/9 Prince
Sattam Street, Al-Khobar, Saudi Arabia
ß 2018 Informa UK Limited, trading as Taylor & Francis Group
2 E. ELSHAMY ET AL.
and its later amendments with all patients signed the
consent form after a thorough explanation of the
study objectives before conducting the study. Ethical
approval number 171k/2015 on 2 April 2015.
Calculation of the sample size was based on the
rate of SSI of 8% from the literature [7], with the
assumption of 50% difference in the rate of SSI
between groups to be clinically significant. This
required a total of 1229 participants for the study to
have a power of 80% at a two-tailed alpha level of
0.05. For compensation of possible drop out cases, a
total of 1484 participants were included with 1424
completed the study (Figure 1: the flow diagram).
All patients intended for elective CS at 34 weeks
and beyond for various obstetric indications were eli-
gible to participate.
Patients with abnormal placentation (previa/accreta),
bleeding tendency, hemoglobin concentration less than
10 g%, with active infection as chorioamnionitis or uro-
genital infection, with skin lesions and/or infection adja-
cent to the operative site, and those with known allergy
to chlorhexidine, alcohol, iodine, as well as those to
whom spinal anesthesia was failed with the need for
general anesthesia, were excluded from the study.
1526 patients were indicated for elective
cesarean section
14 patients with abnormal
placentation, 5 with
bleeding tendency & 12
failed spinal anesthesia
(general anesthesia)
1484 women were recruited
Chlorhexidine-Alcohol group (n=744)
32 patients dropped
out (did not return
to the hospital after
one month).
Chlorhexidine-Alcohol
group (n=712)
Figure 1. Flow diagram of recruitment and retention of participants in the study.
Included patients were equally allocated into two
groups as follows:
Group 1 Chlorhexidine–alcohol (n ¼ 712): skin prepa-
ration was done by chlorhexidine–alcohol (ChloraPrep
with tint 2% w/v/70% v/v; Care Fusion Corporation or
one of its subsidiaries, Basingstoke, Hampshire, UK).
Group 2 Povidone–iodine (n ¼ 712): skin preparation
was done by povidone–iodine (PVP prep scrub
solution; Midline, Laredo, TX).
According to the hospital policy, skin preparation
was performed by the circulating nurse according to
the manufacturer’s instructions for each agent.
The prepackaged antiseptic applicator was opened
and used to scrub the operative site. A waiting
time of 3 minutes was allowed between the applica-
tion of the antiseptic agent and skin incision to allow
the adhesive surgical drapes to stick properly over
dry skin. Preoperative antibiotic prophylaxis was
given according to the hospital policy, cefazolin 1 g
by intravenous injection was administered 1 hour
before the operation.
All participants received spinal anesthesia.
Infection control measures were strictly adhered and
11 patients declined to
participate.
Povidone iodine group (n=740)
28 women dropped
out (did not return to
the hospital after one
month).
Povidone iodine
group (n=712)
 THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE 3

regularly monitored by infection control team in
the hospital.
Skin incision was done through low transverse
incision (Joel–Cohen incision), uterine closure in 2
layers by Vicryl 1, closure of the rectus sheath was
done using Vicryl 1 continuous suture, subcutaneous
tissue was closed using 2/0 monocryl when its thick-
ness is more than 20 mm and the skin was closed by
subcuticular stitches using 2/0 prolene.
Patients were followed up daily and the wound
was uncovered unless soaked and assessed on the
third postoperative day before discharge from the
hospital then follow-up visits were scheduled after 1
week and 1 month postoperatively.
In addition, any patient attended the emergency
room during the entire follow-up period with a com-
plaint regarding surgical wound was reported.
Outcome measures include superficial and deep SSI
after 1 week and within 1 month on the basis of the
National Healthcare Safety Network definitions of the
Centers for Disease Control and Prevention [8], as well
as the need for readmission to hospital or second-
ary suturing.
Statistical analysis
Results were statistically analyzed by SPSS version 20
(SPSS Inc, Chicago, IL). The analysis was performed
on an intention-to-treat basis. Normally distributed
numerical data were presented as a mean and stand-
ard deviation. Non-normally distributed data were
presented as median and range. Qualitative data
were presented as the number and percentage.
Normally distributed numerical data were compared
with unpaired Student’s t-test. Non-normally distrib-
uted numerical data were compared with the
Wilcoxon rank sum test. Qualitative data were
compared using chi-square test. Odds ratio (OR) with
95% confidence interval (CI) was evaluated for the
outcome measures of both groups. For all tests, the
statistical significance was considered when p < .05.
Results
There was no significant difference between the two
groups regarding maternal characteristics in terms of
maternal age, gestational age, body mass index, parity,
previous cesarean deliveries, medical disorders, and
perioperative data (p > .05) as depicted in Table 1.
There was no significant difference between the two
groups regarding the overall rate of SSI, skin irritation
or allergy to the antiseptic used, the need for hospital
readmission or resuturing of the wound (p > .05) as
revealed in Table 2 and illustrated in Figure 2.
Discussion
According to the current study, the overall SSI rates
following elective CS with strict adherence to infection
control measures was around 4% and this is correlat-
ing with the rates of SSI following CS from two recent
randomized trials [6,9] and that rate is less than other
reports [8,10] and this could be explained by the
inclusion of properly prepared elective cases.
In this study, the overall and specific rates of SSI
were comparable in the two groups, as well as the
rates of readmission to hospital and the need for sec-
ondary sutures.
A previous Cochrane review in 2014, found that
chlorhexidine was associated with lower rates of bac-
terial growth at 18 hours after cesarean section com-
pared with iodine; however, there is no difference
between both agents regarding the rate of SSI of
either wound infection or endometritis [11].

Table 1. Maternal characteristics and perioperative data.

Chlorhexidine–alcohol Povidone–iodine Test of
(n ¼ 712) (n ¼ 712) significance p value
Maternal age (years) 25.7 ± 4.9 25.3 ± 5.1 t: 1.51 .13
Gestational age (weeks) 37.5 ± 3.1 37.6 ± 2.9 t: 0.63 .53
Body mass index (kg/m2) 34.2 ± 8.3 33.5 ± 8.7 t: 1.55 .12
Parity: Primipara [n (%)] 140 (19.7%) 154 (21.6%) chi: 0.84 .36
Multipara [n (%)] 572 (80%) 558 (78.4%)
Previous cesarean section scars [n (%)] 498 (70%) 485 (68%) Z: 0.76 .224
Mean operative time (min) 48.5 ± 8 49 ± 8.1 t: 1.17 .24
Estimated blood loss (ml) 582.6 ± 236.9 581.2 ± 230.3 t: 0.11 .9
Hypertension [n (%)] 31 (4.4%) 28 (3.9%) Z: 0.34 .36
Preeclampsia [n (%)] 49 (6.9%) 51 (7.2%) Z: 0.12 .45
Diabetes mellitus [n (%)] 34 (4.8%) 31 (4.4%) Z: 0.23 .4
Gestational diabetes [n (%)] 66 (9.3%) 72 (10.1%) Z: 0.42 .34
Preoperative hemoglobin (g%) 10.8 ± 1.4 10.9 ± 1.6 t: 1.26 .2
Postoperative hemoglobin (g%) 9.9 ± 1.3 10 ± 1.5 t: 1.34 .18
Blood transfusion [n (%)] 36 (5%) 33 (4.6%) Z: 0.23 .4
t: t test, Chi: chi square test, Z: Z test.
4 E. ELSHAMY ET AL.

Table 2. Outcome measures.

Chlorhexidine–alcohol Povidone–iodine
(n ¼ 712) (n ¼ 712) Odds ratio CI at 95% p value
Overall SSI [n (%)] 26 (3.7%) 33 (4.6%) 0.7798 0.46–1.3 .35
Skin separation 10 12 0.83
Hematoma 5 6 0.83 0.35–2 .67
Seroma 9 13 0.69 0.25–2.7 .76
Cellulitis 1 0 – – .39
Deep SSI 1 1 1 0.6–16 1
Necrotizing fasciitis 0 1 – – .39
Resuturing (secondary sutures) [n (%)] 9 (1.26%) 10 (1.4%) 0.9 0.36–2.2 .82
Endometritis [n (%)] 4 (0.56%) 5 (0.7%) 0.8 0.21–0.99 .74
Hospital readmission [n (%)] 19 (2.7%) 21 (2.9%) 0.9 0.48–1.69 .87
Skin irritation or allergic reaction [n (%)] 1 (0.14%) 0 (0%) – – .32
SSI: surgical site infection; CI: confidence interval.

Figure 2. The rate of SSI among patients in the two groups.

A previous randomized controlled trial was
designed primarily to assess the results of skin culture
after skin preparation with chlorhexidine gluconate
versus povidone–iodine among 60 patients under-
going a scheduled CS at 36 gestational weeks and
showed no significant difference in SSI [12].
A previous multicenter randomized study compar-
ing preoperative skin preparation with chlorhexidi-
ne–alcohol to povidone–iodine before clean-
contaminated surgery for adults and found that
chlorhexidine–alcohol is superior to povidone–iodine
for preventing SSI [4].
The findings of this study were in accordance with
the recent meta-analysis that provides no evidence
that skin preparation with chlorhexidine-based anti-
septic has any additional advantage in the reduction
of the risk of SSI after CS [13].
Another recent randomized controlled trial, con-
ducted on 932 patients, found that preoperative skin
preparation with chlorhexidine–alcohol before CS did
not reduce the frequency of SSI compared with povi-
done–iodine which further potentiates findings of the
current study [14].
Chlorhexidine in alcoholic solution has the advan-
tage of faster drying after application to the skin,
which may be advantageous in reducing the time at
the operating rooms.
The large sample size in addition to the lower num-
ber of dropped cases constitutes the main strength of
the current study.
Inability to conduct a randomized trial in addition
to the inclusion of only elective cases constitutes unin-
tended limitations of this study.
Future research should focus on the cost-effective-
ness of various antiseptic agents in both emergency
and elective cesarean deliveries in a larger multicen-
ter trial.
Conclusions
Skin preparation with either chlorhexidine–alcohol or
povidone–iodine resulted in comparable rates of SSIs.
Accordingly, both are suitable antiseptic agents for
skin preparation before elective CS.

Acknowledgments
The authors would like to acknowledge the contribution of
the residents and nursing staff of the operating room at
King Abdul-Aziz Airbase Hospital.
Disclosure statement
No potential conflict of interest was reported by the authors.
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