Clinical trial NCT00290290: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Wound Infection
Keywords: Prevention
Antiseptic Preoperative Scrub
Postoperative Wound Infection
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Michael E. DeBakey VA Medical Center
name: Medical College of Wisconsin
name: US Department of Veterans Affairs
First posted: 2006-02-13
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

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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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Primary outcomes:
measure: 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.
timeFrame: during surgery and within the 30 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: West Roxbury
country: United States
facility: Veterans Affairs Boston Healthcare System
state: Massachusetts
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: Michael E Debakey Medical Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Milwaukee VA Medical Center
state: Wisconsin
Study officials:
affiliation: Baylor College of Medicine
name: Rabih O Darouiche, M.D.
role: STUDY_CHAIR
References:
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.