Back to resultsEfficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
Primary Purpose
Postoperative Wound Infection
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
chlorhexidine-alcohol
Povidone-Iodine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Wound Infection focused on measuring Prevention, Antiseptic Preoperative Scrub, Postoperative Wound Infection
Eligibility 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. - 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. -
Sites / Locations
- Veterans Affairs Boston Healthcare System
- Durham VA Medical Center
- Ben Taub General Hospital
- Michael E Debakey Medical Center
- Medical College of Wisconsin
- Milwaukee VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
povidone-iodine
chlorhexidine-alcohol
Arm Description
preoperative skin preparation with povidone-iodine
preoperative skin preparation with scrub and paint technique
Outcomes
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00290290
First Posted
February 9, 2006
Last Updated
September 10, 2014
Sponsor
Baylor College of Medicine
Collaborators
Michael E. DeBakey VA Medical Center, Medical College of Wisconsin, US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00290290
Brief Title
Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
Official Title
Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical-Site Antisepsis:A Prospective, Randomized, Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Michael E. DeBakey VA Medical Center, Medical College of Wisconsin, US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Infection
Keywords
Prevention, Antiseptic Preoperative Scrub, Postoperative Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
849 (Actual)
8. Arms, Groups, and Interventions
Arm Title
povidone-iodine
Arm Type
Active Comparator
Arm Description
preoperative skin preparation with povidone-iodine
Arm Title
chlorhexidine-alcohol
Arm Type
Experimental
Arm Description
preoperative skin preparation with scrub and paint technique
Intervention Type
Drug
Intervention Name(s)
chlorhexidine-alcohol
Other Intervention Name(s)
Chloraprep
Intervention Description
Preoperative skin preparation with scrub and paint technique
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine
Other Intervention Name(s)
Betadine
Intervention Description
preoperative skin preparation with scrub and paint technique
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
during surgery and within the 30 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
-
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabih O Darouiche, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Boston Healthcare System
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Michael E Debakey Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53214
Country
United States
Facility Name
Milwaukee VA Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53214
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20054046
Citation
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.
Results Reference
derived
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Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
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