Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Postoperative Wound Infection Clinical Trial

Official title:

Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical-Site Antisepsis:A Prospective, Randomized, Multicenter Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290290
• Other study ID #: H-14542
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2006
• Last updated: September 10, 2014
• Start date: September 2003
• Est. completion date: May 2008

Study information

• Verified date: September 2014
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 849
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Postoperative Wound Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• chlorhexidine-alcohol
Preoperative skin preparation with scrub and paint technique
• Povidone-Iodine
preoperative skin preparation with scrub and paint technique

Locations

Country	Name	City	State
United States	Durham VA Medical Center	Durham	North Carolina
United States	Ben Taub General Hospital	Houston	Texas
United States	Michael E Debakey Medical Center	Houston	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Milwaukee VA Medical Center	Milwaukee	Wisconsin
United States	Veterans Affairs Boston Healthcare System	West Roxbury	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	Medical College of Wisconsin, Michael Debakey Veterans Affairs Medical Center, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	during surgery and within the 30 days post surgery	No