NCT01233050

Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

A Randomized Double-Blind Study of 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol vs Iodine Povacrylex [0.7% Available Iodine] / 74% Isopropyl Alcohol for Perioperative Skin Preparation in Open Elective Colorectal Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 802 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex \[0.7% available Iodine\] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.

Conditions

• Colorectal Surgery

Interventions

Type	Name	Description
DRUG	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol	Preoperative skin antisepsis preparation
DRUG	Iodine Povacrylex/74% Isopropyl Alcohol	preoperative skin antisepsis preparation

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2010-11-02
• Last updated: 2018-07-18
• Results posted: 2017-09-05

Locations

3 sites across 1 country: United States