Purpose: To compare the effect of chlorhexidine-alcohol and povidone iodine on surgical site infection (SSI) after caesarean section. Methodology: A randomized control trial of 374 patients (188 in the chlorhexidine-alcohol group and 186 in the povidone iodine group) who had elective caesarean section with no overt risk for SSI was done. Patients were followed up until thirty days after delivery to assess for symptoms and signs of SSI. Results: Fifty-one (13.6%) of the study population developed SSI. Although the incidence of SSI was lower in the chlorhexidine-alcohol group than the povidone iodine group (12.2% vs. 15.1%; p = 0.26); the difference was not statistically significant. The incidence of adverse skin reaction in Chlorhexidine-alcohol vs. povidone iodine was also not statistically significant (4.0% vs. 5.4%; p = 0.40). Conclusion: The study demonstrates that there was no statistically significant difference in antiseptic property and side effect profile of chlorhexidine-alcohol and povidone-iodine when used as skin antisepsis in caesarean section.
Surgical site infection (SSI) occurs in 5% - 10% of caesarean deliveries [
The skin being a major source of pathogens that cause SSI, thus requires, proper preoperative skin preparation in order to decrease the likelihood of SSI [
This randomized control trial was carried out in the Department of Obstetrics and Gynaecology of the Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife, Osun State, Nigeria between August 2012 and July 2013. The study was approved by the Ethics committee of the hospital and all participants provided informed consent. Sample size was determined based on the formula for estimating sample size for the comparison of two independent population as described by Armitage et al. [
A total of 384 patients (192 in each of chlorhexidine-alcohol and povidone iodine group) who had elective caesarean section at OAUTHC, Ile-Ife were randomized into either group after informed consent was obtained. Patients with known allergy to chlorhexidine or povidone-iodine; immunocompromised patients and those with previous midline scar were excluded from the study. Patients with overt risk for infection like obstructed labour, prolong prelabour rupture of membranes, maternal febrile conditions were excluded.
Randomization was achieved using sequentially numbered sealed packets from a computer generated random sequence. The sealed envelopes were placed in the labour ward theatre and were drawn from serially by the surgeons just before the procedure. Blinding both patients and physicians to the antiseptic used for skin preparation (double-blinding) would have been ideal, however, it was not feasible in this trial. Systematic bias was minimised by using the same standard procedures of skin preparation, skin culture and assessment of outcomes.
Prior to surgery, all patients had a bath with a non-antiseptic soap to include the area of surgery. Shaving of the lower abdomen was done on the surgical table just before commencing antiseptic skin preparation. Subjects had pfannenstiel incision, which was closed with vicryl 2/0 subcuticular sutures. The subcutaneous layer was closed with vicryl 2/0. The surgery was done under spinal anaesthesia unless otherwise indicated. Demographic, obstetric, neonatal data and variables known to be related to SSI were recorded.
For patients who fell into the chlorhexidine-alcohol group, skin preparation with gauze soaked in Valon® (containing Chlorhexidine gluconate 0.3% w/v and Cetrimide 3.0% w/v manufactured by Royal priesthood laboratory ltd) which was diluted with distilled water in a 1:1 ratio was done. A centrifugal scrubbing motion was used starting from the area of the intended incision and covered the abdomen from the subcoastal margin to the midaxillary line down to the middle of the thigh. This was repeated twice. The area was then dried with a piece of dry gauze in the same centrifugal manner. Moko® (containing Isopropyl alcohol 95% v/v manufactured by New-Health way Co. Limited) was then applied on the area in the same centrifugal manner and allowed to dry before draping off the area.
For patients who fell into the povidone iodine group, Wosan® (containing 10% povidone iodine manufactured by Jawa international limited) was used. The povidone iodine was painted on the aforementioned area and then left to dry completely before draping the area and commencing the surgery.
The same prophylactic antibiotic-intravenous cefuroxime 750 mg stat was administered after clamping of the cord. The placenta was removed with gentle traction and exterior massage of the uterus, and removed manually only if it was retained for more than 5 minutes. The uterus was then exteriorized before repair. On completion of the surgery, a standard sterile gauze dressing kept in place with plaster to ensure non-exposure of the gauze and underlying wound was applied. The patients were then counseled to keep the wound dressings dry.
Postoperatively, the patients’ wound and area of the skin on which the antiseptics was applied were inspected on the third and seventh day. The dressing was changed on the third post operative day or earlier if soaked. Wounds that were determined to be infected had wound swabs taken for microscopy, culture and sensitivity and daily dressings instituted as appropriate. A modification of the Southampton’s wound infection scoring system [
After discharge, the women were instructed about the signs and symptoms of wound infection and they were given written information leaflets about SSI. Subjects were contacted weekly up to 30 days from delivery, to assess symptoms of surgical site infections. Patients who reported symptoms were evaluated at the obstetric emergency unit for surgical site infection.
Study data was processed using SPSS version 17 (IBM, Armonk, NY, USA). Frequency tables were made and results were tested for significance using the student t-test for continuous variables and chi square or Fisher exact test for categorical variables with level of significance (x) set at 0.05.
Three hundred and eighty-four patients who had elective caesarean section were recruited into the study. Ten were excluded from the analysis due to the fact that they were lost to follow up or ended up having a midline scar. One hundred and eighty-eight were in the chlorhexidine-alcohol group and one hundred and eighty-six in the povidone iodine group.
The incidence of 13.6% for SSI in this study was comparable to the incidence of 10% finding by Fasubaa et al. [
The findings from this study show that there is no statistically significant difference in the incidence of SSI (12.2% vs. 15.1%; p = 0.26) in both groups. Although there was a 19% reduction in incidence of SSI in the chlorhexidine-alcohol group, this was lower than the findings of Darouchie et al. [
The finding of beneficial effect of chlorhexidine-alcohol over povidone iodine, however, contrasts with the findings of Swenson et al. [
A Cochrane review of skin preparation for preventing infection following caesarean section [
Characteristic | Total patient population N = 374 | Chlorhexidine-alcohol group N = 188 | Povidone iodine group N = 186 | P value |
---|---|---|---|---|
Mean age (years) | 32.01 ± 6.13 | 32.13 ± 6.03 | 31.89 ± 6.25 | 1.00 |
Parity | 1.61 ± 0.42 | 1.60 ± 0.59 | 1.70 ± 0.64 | 0.84 |
Social class I II III IV V | 156 (41.7%) 133 (35.6%) 69 (18.4%) 15 (4.0%) 1 (0.3%) | 75 (39.9%) 66 (35.1%) 41 (21.8%) 5 (2.7%) 1 (0.5%) | 81(43.5%) 67 (36.0%) 28 (15.1%) 10 (5.4%) 0 | 0.25 |
Tribe Yoruba Ibo Hausa Others | 277 (74.1%) 59 (15.8%) 20 (5.3%) 18 (4.8%) | 139 (73.9%) 30 (16.0%) 10 (5.3%) 9 (4.8%) | 138 (74.2%) 29 (15.6%) 10 (5.4%) 9 (4.8%) | 1.00 |
Occupation Professional Artisan Housewife Student | 140 (37.4%) 60 (16.0%) 96 (25.7%) 78 (20.9%) | 70 (37.2%) 28 (14.9%) 50 (26.6%) 40 (21.3%) | 70 (37.6%) 32 (17.3%) 46 (24.7%) 38 (20.4%) | 0.93 |
Educational status Tertiary Secondary Primary No formal education | 204 (54.5%) 112 (29.9%) 35 (9.4%) 23 (6.1%) | 104 (55.3%) 55 (29.3%) 18 (9.6%) 11 (5.8%) | 100 (53.8%) 57 (30.6%) 17 (9.1%) 12 (6.5%) | 0.98 |
Body mass index Normal Over weight Obese | 23.75 ± 3.33 280 (74.9%) 61 (16.3%) 33 (8.8%) | 23.70 ± 3.26 141 (75.0%) 31 (16.5%) 16 (8.5%) | 23.81 ± 3.43 139 (74.7%) 30 (16.1%) 17 (9.2%) | 0.98 |
Indications for surgery 1 caesarean section + another complication Major placenta praevia 2 previous C/S or more Abnormal lie at term Previous uterine surgery Breech presentation Others | 115 (30.7%) 54 (14.4%) 53 (14.3%) 43 (11.5%) 24 (6.4%) 45 (12.0%) 40 (10.7%) | 61 (32.4%) 32 (17.0%) 27 (14.4%) 24 (12.8%) 12 (6.4%) 20 (10.6%) 12 (6.4%) | 54 (29.0%) 22 (11.8%) 26 (14.0%) 19 (10.2%) 12 (6.5%) 25 (13.4%) 28 (15.1%) | 0.13 |
Duration of surgery Less than 1 hour More than 1 hour | 371 (99.2%) 3 (0.8%) | 187 (99.5%) 1 (0.5%) | 184 (98.9%) 2 (1.1%) | 0.56 |
Anaesthesia used Spinal General | 371 (99.2%) 3 (0.8%) | 186 (98.9%) 2 (1.1%) | 185 (99.5%) 1 (0.5%) | 0.57 |
Type of skin reaction | Chlorhexidine-alcohol group N = 188 | Povidone iodine group N = 186 | Total N = 374 | P value |
---|---|---|---|---|
Any skin reaction | 8 (4.4%) | 10 (5.4%) | 18 (4.8%) | 0.40 |
Pruritus | 4 (2.2%) | 6 (3.2%) | 10 (2.7%) | |
Erythema | 4 (2.2%) | 4 (2.2%) | 8 (2.1%) |
Type of surgical site infection | Chlorhexidine-alcohol group N = 188 | Povidone iodine group N = 186 | Total N = 374 | P value |
---|---|---|---|---|
Any type of surgical site infection | 23 (12.2%) | 28 (15.1%) | 51 (13.6%) | 0.26 |
I Normal healing with mild bruising or erythema | 3 (1.6%) | 4 (2.2%) | 7 (1.9%) | |
II Erythema plus other signs of inflammation | 7 (3.7%) | 10 (5.3%) | 17 (4.5%) | |
III Clear or haemoserous discharge | 7 (3.7%) | 6 (3.2%) | 13 (3.5%) | |
IV Pus | 5 (2.7%) | 7 (3.8%) | 12 (3.2%) | |
V Deep or severe wound infection with/without tissue breakdown | 1 (0.5%) | 1 (0.5%) | 2 (0.5%) | |
Microorganism cultured | ||||
Staphylococcus aureus | 10 (5.3%) | 11 (5.9%) | 21 (5.6%) | |
Escherichia coli | 6 (3.2%) | 8 (4.3%) | 14 (24.1%) | |
Pseudomonas aeruginosa | 3 (1.6%) | 3 (1.6%) | 6 (3.7%) | |
Proteus mirabilis | 4 (2.1%) | 6 (3.2%) | 10 (2.7%) |
forms, concentrations and methods of skin preparation for preventing infection following caesarean section” [
Most of the cases of SSI were of the superficial type which was similar to findings of other investigators [
Incidence of skin reaction was found to be higher in the povidone iodine group than the chlorhexidine-alcohol group. The reaction consisted mainly of pruritus and erythema but none was life threatening. These reactions were attributed to the antiseptic because they involved the entire area the antiseptic was used on and not just the incision site.
The true incidence of chlorhexidine allergy is unknown [
The result of this study shows that although chlorhexidine-alcohol skin antiseptic has some benefit over povidone iodine in terms of lower incidence of SSI and skin reaction, the evidence is not sufficient enough to recommend it over povidone iodine. The study goes further to serve as a reference for future work involving skin antiseptics and caesarean section.
We thank Consultant staff and members of the Department of Obstetrics and Gynaecology Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Osun state.
OlufemiAworinde,KehindeOlufemi-Aworinde,AkintundeFehintola,BabalolaAdeyemi,MusliudinOwonikoko,Adewale SamsonAdeyemi, (2016) Antiseptic Skin Preparation for Preventing Surgical Site Infection at Caesarean Section. Open Journal of Obstetrics and Gynecology,06,246-251. doi: 10.4236/ojog.2016.64031