Overview

Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Status:
Completed

Trial end date:
2008-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Baylor College of Medicine

Collaborators:

Medical College of Wisconsin
Michael Debakey Veterans Affairs Medical Center
Michael E. DeBakey VA Medical Center
US Department of Veterans Affairs
VA Office of Research and Development

Treatments:

Anti-Infective Agents, Local
Cadexomer iodine
Chlorhexidine
Chlorhexidine gluconate
Ethanol
Iodine
Povidone
Povidone-Iodine

Criteria

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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