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Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Wound Infections

This study has been completed.
Sponsor:
Collaborators:
Michael Debakey Veterans Affairs Medical Center
Medical College of Wisconsin
Department of Veterans Affairs
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00290290
First received: February 9, 2006
Last updated: July 16, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Wound Infection
 Drug: Chloraprep
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Chloraprep vs. Betadine for Prevention of Clean-Contaminated Surgical Wounds: A Prospective, Randomized, Multicenter Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • The secondary objectives are to 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.

Estimated Enrollment: 1114
Study Start Date: September 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 iodophores.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290290

Locations
United States, Massachusetts
Veterans Affairs Boston Healthcare System
West Roxbury, Massachusetts, United States, 02132
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
United States, Texas
Michael E Debakey Medical Center
Houston, Texas, United States, 77030
Ben Taub General Hospital
Houston, Texas, United States, 77030
United States, Wisconsin
Milwaukee VA Medical Center
Milwaukee, Wisconsin, United States, 53214
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53214
Sponsors and Collaborators
Baylor College of Medicine
Michael Debakey Veterans Affairs Medical Center
Medical College of Wisconsin
Department of Veterans Affairs
Investigators
Study Chair: Rabih O Darouiche, M.D. Baylor College of Medicine
  More Information

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rabih Darouiche, MD, Baylor College of Medicine; Michael E. DeBakey VA Medical Center
ClinicalTrials.gov Identifier: NCT00290290     History of Changes
Other Study ID Numbers: H-14542
Study First Received: February 9, 2006
Last Updated: July 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Prevention
Antiseptic Preoperative Scrub
Postoperative Wound Infection

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Anti-Infective Agents, Local
 Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013