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Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00290290
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : August 11, 2014
Last Update Posted : September 18, 2014
Sponsor:
Collaborators:
Michael Debakey Veterans Affairs Medical Center
Medical College of Wisconsin
US Department of Veterans Affairs
Information provided by (Responsible Party):
Rabih Darouiche, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Postoperative Wound Infection
Interventions Drug: chlorhexidine-alcohol
Drug: Povidone-Iodine
Enrollment 849
Recruitment Details Patients 18 years or older undergoing clean-contaminated surgery preformed without substantial spillage or unusual contamination were eligible for enrollment. Patients were excluded if they were allergic to chlorhexidine, alcohol, or iodophors, or had infection at or adjacent to operative site, & if there was a perceived inability for a 30 days F/U
Pre-assignment Details There were no significant events prior to group assignment. Enrolled patients were immediately and randomly assigned in a 1:1 ratio to a study arm. To help match the two groups and address potential inter-hospital differences, randomization was stratified by hospital with the use of computer-generated randomization numbers without blocking
Arm/Group Title Povidone-Iodine Chlorhexidine-Alcohol
Hide Arm/Group Description Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
Period Title: Overall Study
Started 440 409
Completed 422 391
Not Completed 18 18
Reason Not Completed
Death             3             4
Withdrawal by Subject             2             2
Underwent clean surgical procedure             13             12
Arm/Group Title Povidone-iodine Chlorhexidine-alcohol Total
Hide Arm/Group Description Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol Total of all reporting groups
Overall Number of Baseline Participants 440 409 849
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 440 participants 409 participants 849 participants
52.9  (14.2) 53.3  (14.6) 53.1  (14.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 440 participants 409 participants 849 participants
<18 years 0 0 0
>18 years 440 409 849
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 440 participants 409 participants 849 participants
Female
194
  44.1%
168
  41.1%
362
  42.6%
Male
246
  55.9%
241
  58.9%
487
  57.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 440 participants 409 participants 849 participants
440 409 849
1.Primary Outcome
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Povidone-Iodine Chlorhexidine-Alcohol
Hide Arm/Group Description:
Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
Overall Number of Participants Analyzed 440 409
Measure Type: Number
Unit of Measure: Percentage of Post Operative Infections
16.1 9.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Povidone-Iodine, Chlorhexidine-Alcohol
Comments The average baseline rate of surgical-site infection at the six participating hospitals was 14% after clean-contaminated surgery with povidone-iodine skin preparation, and we estimated that substituting chlorhexidine-alcohol for povidone-iodine would reduce this rate to 7%. Therefore, we planned to enroll approximately 430 patients in each study group who could be evaluated in order for the study to have 90% power to detect a significant difference in the rates of surgical-site infection.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.41 to 0.85
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Povidone-Iodine Chlorhexidine-Alcohol
Hide Arm/Group Description Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
All-Cause Mortality
Povidone-Iodine Chlorhexidine-Alcohol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Povidone-Iodine Chlorhexidine-Alcohol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/440 (0.68%)      4/409 (0.98%)    
Surgical and medical procedures     
Death  [1]  3/440 (0.68%)  3 4/409 (0.98%)  4
Indicates events were collected by systematic assessment
[1]
Death was NOT judged to be related to the study drugs in either group.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.7%
Povidone-Iodine Chlorhexidine-Alcohol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/440 (0.68%)      3/409 (0.73%)    
Skin and subcutaneous tissue disorders     
Pruritis/Erythema   3/440 (0.68%)  3 3/409 (0.73%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rabih Darouiche, M.D.
Organization: Baylor College of Medicine
Phone: 713-794-8858
EMail: rabihd@bcm.edu
Layout table for additonal information
Responsible Party: Rabih Darouiche, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00290290    
Other Study ID Numbers: H-14542
First Submitted: February 9, 2006
First Posted: February 13, 2006
Results First Submitted: November 15, 2012
Results First Posted: August 11, 2014
Last Update Posted: September 18, 2014