Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Wound Infections - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 9, 2006

Last Updated Date

July 16, 2008

Start Date ^†

September 2003

Current 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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00290290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Wound Infections

Official Title ^†

Chloraprep vs. Betadine for Prevention of Clean-Contaminated Surgical Wounds: 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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Postoperative Wound Infection

Intervention ^†

Drug: Chloraprep

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

1114

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

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 iodophores.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00290290

Responsible Party

Rabih Darouiche, MD, Baylor College of Medicine; Michael E. DeBakey VA Medical Center

Secondary IDs ^††

Study Sponsor ^†

Baylor College of Medicine

Collaborators ^††

Michael Debakey Veterans Affairs Medical Center
Medical College of Wisconsin
Department of Veterans Affairs

Investigators ^†

Study Chair:

Rabih O Darouiche, M.D.

Baylor College of Medicine

Information Provided By

Baylor College of Medicine

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.