Aim: Clinical evaluation of preoperative skin preparation with aqueous povidoneiodinealone and in combination with alcoholic chlorhexidine in patients undergoing electivesurgery Material and methods: This observational study was carried out in the Department of General Surgery Saraswathi Institute of Medical Scienecs ,Hapur. 120 Patients of all age groups undergoing elective surgery in the Department of General Surgery with a clean wound were included in this study. 120 patients divided into 2 equals groups. For Group 1 antiseptic regimen used is three coats of aqueous povidone-iodine IP5%w/v. For Group-2 antiseptic regimen used is a single coat of agent containing chlorhexidine gluconate 2.5% v/v in 70% propanol followed by two coats of aqueous povidone-iodine IP 5% w/v. The pre- operative antibiotic used is Cefotaxime 1 gram I.V given following a test dose;one hour prior to incision. Results: There are 7 patients in group-1 and 2 patients in group-2 who had positive culture which is found to be statistically significant. Post-operatively patients were followed upto the time of suture removal (usually 7-10 days) to know the percent of cases who developed wound infections. There were 7 cases in group-1 and 2 case in group-2 who developed postoperative wound infections. It is noted that out of 7 cases with growth ingroup-1, only 4 had post-operative wound infection and the other 3 were ward acquired. Similarly, the only infection in group-2 is hospital acquired. Conclusion: The present study confirms the superiority of povidone-iodine in combination with alcoholic chlorhexidine over povidone-iodine alone in pre-operative skin preparation and warrants recommendation of it as a preferred antiseptic in skin preparation for elective clean surgery.
Surgical-site infection (SSI) represents a major source of morbidity and mortality among surgical patients.1,2 Infection of the surgical wound can prolong hospitalization, 3 increase the rate of intensive care unit admission, 4 and significantly increase the cost of treatment.5,6 Integral tothe prevention of SSI is the adherence to a septic techniques, one of which is the pre operative preparation of the operative site . Several skin preparation modalities are approved by the Food and Drug Administration and are in use in operating rooms today. Chlora Prep (Cardinal Health) is a commercially available combination of 2% chlorhexidine and 70% isopropylalcohol. The combination of chlorhexidine and isopropyl alcohol (or 70% isopropyl alcoholalone) has significantly better immediate antimicrobial activity than does 4% chlorhexidine. Also ,the combination of chlorhexidine and isopropylalcohol has demonstrated better residual antimicrobial activity than either 70% isopropyl alcohol alone or 4% chlorhexidine alone. 7 In other trials, 2% chlorhexidine and 70% isopropyl alcohol demonstrated better immediate and long-term residual antimicrobial activity than did povidone-iodine alone. 8 This finding hasbeen observed clinically as well: Maki et al 9 observed that cutaneous disinfection with chlorhexidine before insertion of an intravascular device and for post insertion site care can substantially reduce the incidence of device related infection ,compared with cut aneous disinfection with povidone-iodine. Another skin disinfectant solution, consisting of iodinepovacrylex in isopropyl alcohol (Dura Prep; 3M), is commercially available and has become popular for surgical disinfection.10,11 Iodine povacrylex in isopropyl alcohol solution may provide longer-lasting antisepsis than other iodophor-based products because, when placed on skin, it dries to a film of disinfectant. It has been suggested that this film may resist being washed away by fluids and blood and thus may provide potential for longer-term protection than traditional povidone-iodine. 12 become popular for surgical disinfection.10,11 Iodine povacrylex in isopropyl alcohol solution may provide longer-lasting antisepsis than other iodophor-based products because, when placed on skin, it dries to a film of disinfectant. It has been suggested that this film may resist being washed away by fluids and blood and thus may provide potential for longer-term protection than traditional povidone-iodine. 12
This observational study was carried out in the Department of General Surgery after taking the approval of the protocol review committee and institutional ethics committee. 120 Patients of all age groups undergoing elective surgery in the Department of General Surgery with a clean wound were included in this study. patients with Immuno compromised, on long term steroids, Patients with septicaemia and having a focus of infection somewhere on the body manifested clinically with fever and increased total and differential counts and Clean contaminated and contaminated surgeries in which viscous was opened were excluded from the study.
METHODOLOGY
120 patients divided into 2 equals groups. Cases were selected at random irrespective of each case preoperatively, shaving of the parts was done at the same time on the previous evening for all the patients. The preoperative skin preparation in each group is done with the respective antiseptic regimen. For Group-1 antiseptic regimen used is three coats of aqueous povidoneiodine IP 5% w/v. For Group-2 antiseptic regimen used is a single coat of agent containing chlorhexidine gluconate 2.5%v/vin70% propanol followed by two coats of aqueous povidone-iodine IP5%w/v. The pre-operative antibiotic use dis Cefotaxime 1 gramI. V given following a test dose; one hour prior to incision. A sterile saline swab culture & sensitivity is done from the site of incision immediately in both the groups. This had important implications in knowing whether these strains were responsible for causing infections in the postoperative period.
STATISTICAL ANALYSIS
Statistical analysis was performed using SPSS Statistics V25.0. Results were represented with frequencies and percentages. The Chi-square test and Fischer exact test were applied to find significance. P<0.05 was considered statistically significant.
A total of 120 patients who were planned for clean elective surgery were studied in two groups (60 in each group). The Mean (SD) value of the age for group-1 was 39.7 + 13.4 and that forgroup2was 37.7 +14.9years and the difference is not statistically significant.
There were 72 males (Group I - 32; Group II – 40) and 48 females (Group I - 28; Group II – 20). Duration of surgeries varied from 46 minutes to 3.10 hours and since all the surgeries were clean and elective, the duration of surgery has no effect on the number of cases with positive cultures wabs. There are 7 patients in group-1 and 2 patients in group-2 who had positive culture which is found to be statistically significant. The culture and antibiotic sensitivity result soft hepatients with growth in both groups are summarized in table 5. Post-operatively patients were followed up to the time of suture removal (usually 7-10 days) to know the percent of cases who developed wound infections. There were 7 cases in group-1and 2 case in group-2 who developed postoperative wound infections. It is noted that out of 7cases with growth in group-1, only 4 had post-operative wound infection and the other 3 were ward acquired. Similarly, the only infection in group-2is hospital acquired.
The use of PVP-iodine in surgeries dates to 1955. Chlorhexidine gluconate with its increase defficiency has been recently made available all over as an antiseptic and disinfectant. In this study, we compared the efficacy of povidone-iodine alone and in combination with alcoholic chlorhexidine in elective clean surgeries for the prevention of surgical site infections. The present study has 11.67% in group-1 and 3.33% in group 2 had colonization of site of incision even after skin disinfection where as the respective values in JuliaL etal .13 studies were 35.3%and 4.7% and in Ajay et al.14 study were 20.8% and 3.3% This shows that when compared to povidone-iodine alone, using a combination of povidone- iodine and an alcoholic solution of chlorhexidine, the colonization rates of the sites of incision were reduced significantly. The rate of postoperative wound infections (after excluding ward infections) in group-1 is 6.67%and of group-2 is 0% whereas the respective values in Brown et al.15 studies were 8.1% and6.0%, Ajay et al.14 studies were 13.3% and 0%. The difference in the results was not that significant in studies done by Park et al.16 ,Sistla et al.17 and Paocharoen et al.18 [The results from the present study show that preoperative skin preparation using chlorhexidine gluconate2.5% v/v in 70% propanol followed by aqueous povidone-iodine 5% w/v is effective when compared with aqueous povidone iodine alone. The limitations of our study include convenient sample size and lack of diversity in patients, asitis a single-center study.
The present study confirms the superiority of povidone-iodine in combination with alcoholic chlorhexidine over povidone-iodine alonein pre-operative skin preparation and warrants recommendation of it as a preferred antiseptic in skin preparation for elective clean surgery.