Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE February 9, 2006
First Posted Date  ICMJE February 13, 2006
Results First Submitted Date  ICMJE November 15, 2012
Results First Posted Date  ICMJE August 11, 2014
Last Update Posted Date September 18, 2014
Study Start Date  ICMJE September 2003
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2006)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2006)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
Official Title  ICMJE Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical-Site Antisepsis:A Prospective, Randomized, Multicenter Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Wound Infection
Intervention  ICMJE
  • Drug: chlorhexidine-alcohol
    Preoperative skin preparation with scrub and paint technique
    Other Name: Chloraprep
  • Drug: Povidone-Iodine
    preoperative skin preparation with scrub and paint technique
    Other Name: Betadine
Study Arms  ICMJE
  • Active Comparator: povidone-iodine
    preoperative skin preparation with povidone-iodine
    Intervention: Drug: Povidone-Iodine
  • Experimental: chlorhexidine-alcohol
    preoperative skin preparation with scrub and paint technique
    Intervention: Drug: chlorhexidine-alcohol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2014)
849
Original Enrollment  ICMJE
 (submitted: February 9, 2006)
1114
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00290290
Other Study ID Numbers  ICMJE H-14542
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rabih Darouiche, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE
  • Michael Debakey Veterans Affairs Medical Center
  • Medical College of Wisconsin
  • US Department of Veterans Affairs
Investigators  ICMJE
Study Chair: Rabih O Darouiche, M.D. Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP