Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

NCT00290290 | Completed Phase 3 Results DMC

• 1 other identifier: H-14542
• Study Type: interventional
• Target: 849
• Locations: 1 country
• Sites: 6

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.

Conditions

Postoperative Wound Infection

Keywords

Prevention; Antiseptic Preoperative Scrub; Postoperative Wound Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

povidone-iodine

ACTIVE COMPARATOR

preoperative skin preparation with povidone-iodine

Drug: Povidone-Iodine

chlorhexidine-alcohol

EXPERIMENTAL

preoperative skin preparation with scrub and paint technique

Drug: chlorhexidine-alcohol

Interventions

chlorhexidine-alcohol DRUG

Preoperative skin preparation with scrub and paint technique

Also known as: Chloraprep

chlorhexidine-alcohol

Povidone-Iodine DRUG

preoperative skin preparation with scrub and paint technique

Also known as: Betadine

povidone-iodine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Michael E. DeBakey VA Medical Center: collaborator
• Medical College of Wisconsin: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (6)

Veterans Affairs Boston Healthcare System

West Roxbury, Massachusetts, 02132, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Michael E Debakey Medical Center

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53214, United States

Location

Milwaukee VA Medical Center

Milwaukee, Wisconsin, 53214, United States

Location

Related Publications (1)

• Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

  PMID: 20054046 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Chlorhexidine; Ethanol; Povidone-Iodine

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Alcohols; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Rabih Darouiche, M.D.
• Organization: Baylor College of Medicine

rabihd@bcm.edu

713-794-8858

Study Officials

• Rabih O Darouiche, M.D.

  Baylor College of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: September 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 18, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-09

Locations

US (6)