Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

This study has been completed.
Sponsor:
Collaborators:
Michael Debakey Veterans Affairs Medical Center
Medical College of Wisconsin
Information provided by (Responsible Party):
Rabih Darouiche, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00290290
First received: February 9, 2006
Last updated: July 18, 2014
Last verified: July 2014
  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: chlorhexidine-alcohol
Drug: Povidone-Iodine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical-Site Antisepsis:A Prospective, Randomized, Multicenter Clinical Trial

Resource links provided by NLM:


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. [ Time Frame: during surgery and within the 30 days post surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 849
Study Start Date: September 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: povidone-iodine
preoperative skin preparation with povidone-iodine
Drug: Povidone-Iodine
preoperative skin preparation with scrub and paint technique
Other Name: Betadine
Experimental: chlorhexidine-alcohol
preoperative skin preparation with scrub and paint technique
Drug: chlorhexidine-alcohol
Preoperative skin preparation with scrub and paint technique
Other Name: Chloraprep

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 iodophors.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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, Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00290290     History of Changes
Other Study ID Numbers: H-14542
Study First Received: February 9, 2006
Results First Received: November 15, 2012
Last Updated: July 18, 2014
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
Ethanol
Anti-Infective Agents, Local
Chlorhexidine
Chlorhexidine gluconate
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 14, 2014