Randomized Controlled Trial Evaluating the Efficacy and Cost Effectiveness of a Ready-to-Use Applicator Containing Iodine Povacrylex and Isopropyl Alcohol Compared with Conventional Skin Scrubbing and Painting in Patients Undergoing Colorectal Surgery

Abstract

Objective: The aim of this study was to evaluate the efficacy and cost-effectiveness of a ready-to-use applicatorcontaining iodine povacrylex and isopropyl alcohol (IPIA) for the prevention of surgical site infection (SSI) followingintra-abdominal surgery.Materials and Methods: The IPIA was randomly used in patients who underwent colorectal surgical procedures.The control group for comparison was a group of patients who underwent colorectal surgical procedures usingconventional skin scrubbing and painting with antiseptic solutions without IPIA. In total, 100 patients were includedin the study, randomized into 2 groups: one was applied IPIA and another group a conventional skin preparation.The outcome measurements included ease-of-use as assessed by a questionnaire, preparation time comparison,estimated skin preparation expense, adverse reactions, and rate of SSI. All the patients were visited daily up to 7 dayspostoperation or until discharge, and then 14 and 30 days postoperatively for monitoring the occurrence of SSI.Results: Of the 100 patients undergoing elective intra-abdominal surgery enrolled in the study, 51 were males and49 females, with the mean age of 63.5 ± 11.3 years. The majority of the patients had undergone colorectal cancercolectomies or rectal resections. There was no mortality. Seven patients (7%) had postoperative SSI (4 patients inthe control group and 3 patients in the IPIA group, 4% vs. 3%, p = 0.45). The bacterial cultures revealed Gramnegative-bacilli in all of the patients with SSI. The preparation time for the skin preparation was 5.48 ± 2.49 min inthe control group and 2.65 ± 1.55 min in the IPIA group (p = 0.002), without statistical significance of expenses.Conclusion: IPIA was demonstrated to be as safe and effective as conventional antiseptic solutions as a skinpreparation to prevent SSI following colorectal surgery. With good ease of use, IPIA proved more convenient thana scrubbing preparation as well as offered better cost effectiveness by significantly reducing the time and cost ofthe skin preparation.