Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

• 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: Baylor College of Medicine
• Collaborators: Michael E. DeBakey VA Medical Center; Medical College of Wisconsin; US Department of Veterans Affairs
• Information provided by (Responsible Party): Rabih Darouiche, Baylor College of Medicine

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Wound Infection	Drug: chlorhexidine-alcohol; Drug: Povidone-Iodine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 849 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical-Site Antisepsis:A Prospective, Randomized, Multicenter Clinical Trial
• Study Start Date: September 2003
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: May 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Ben Taub General Hospital

Houston, Texas, United States, 77030

Michael E Debakey Medical Center

Houston, Texas, United States, 77030

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53214

Milwaukee VA Medical Center

Milwaukee, Wisconsin, United States, 53214

Sponsors and Collaborators

Baylor College of Medicine

Michael E. DeBakey VA Medical Center

Medical College of Wisconsin

US Department of Veterans Affairs

Investigators

• Study Chair: Rabih O Darouiche, M.D.; Baylor College of Medicine

More Information

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

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.

• Responsible Party: Rabih Darouiche, Professor of Medicine, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00290290
• Other Study ID Numbers: H-14542
• First Posted: February 13, 2006
• Results First Posted: August 11, 2014
• Last Update Posted: September 18, 2014
• Last Verified: September 2014

Keywords provided by Rabih Darouiche, Baylor College of Medicine:

Prevention; Antiseptic Preoperative Scrub; Postoperative Wound Infection

Additional relevant MeSH terms:

Infections; Wound Infection; Surgical Wound Infection; Pathologic Processes; Postoperative Complications; Chlorhexidine; Povidone-Iodine; Povidone; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Plasma Substitutes; Blood Substitutes