Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Phase 3

Completed

• Conditions: Postoperative Wound Infection
• Interventions: Drug: Povidone-Iodine; Drug: chlorhexidine-alcohol

• Registration Number: NCT00290290
• Lead Sponsor: Baylor College of Medicine

Brief Summary

Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.

Detailed Description

This is a prospective, randomized, multicenter clinical trial. All adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-13
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2012-11-15
• Results First Submitted QC: 2014-07-18
• Results First Posted: 2014-08-11
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 849

Inclusion Criteria

Adult patients who are scheduled for a clean-contaminated surgical procedure of the alimentary or respiratory tract will be eligible for participation. A clean-contaminated wound is one that is entered under controlled conditions without unusual contamination.

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Exclusion Criteria

Patients will be excluded form the study if: (1) they are unable or unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine, alcohol or iodophors.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
povidone-iodine	Povidone-Iodine	preoperative skin preparation with povidone-iodine
chlorhexidine-alcohol	chlorhexidine-alcohol	preoperative skin preparation with scrub and paint technique

Primary Outcome Measures

Name	Time	Method
The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds.	during surgery and within the 30 days post surgery	The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.

Trial Locations

Locations (6)

Milwaukee VA Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

Veterans Affairs Boston Healthcare System; 🇺🇸 West Roxbury, Massachusetts, United States

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States

Durham VA Medical Center; 🇺🇸 Durham, North Carolina, United States

Michael E Debakey Medical Center; 🇺🇸 Houston, Texas, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States