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Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

NCT00290290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 849

Last updated 2014-09-18

Study results available
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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

Interventions

DRUG

chlorhexidine-alcohol

Preoperative skin preparation with scrub and paint technique

DRUG

Povidone-Iodine

preoperative skin preparation with scrub and paint technique

Sponsors & Collaborators

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • Medical College of Wisconsin

    collaborator OTHER

  • US Department of Veterans Affairs

    collaborator FED

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Rabih O Darouiche, M.D. · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290290 on ClinicalTrials.gov