CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 802 enrolled
Drug / intervention
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01233050
NCT01233050N/ACompleted

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

University of Pennsylvania·interventional·Posted Nov 2, 2010·Updated Jul 18, 2018

In Brief

A clinical study evaluating 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol and Iodine Povacrylex/74% Isopropyl Alcohol for Colorectal Surgery. Completed, enrolled 802 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators3M

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2010
Enrollment StartDec 1, 2010
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.7 years ago

Interventions

2% Chlorhexidine Gluconate/70% Isopropyl Alcoholdrug

Preoperative skin antisepsis preparation

Iodine Povacrylex/74% Isopropyl Alcoholdrug

preoperative skin antisepsis preparation