Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

NCT ID: NCT00290290

Last Updated: 2014-09-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

849 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

povidone-iodine

preoperative skin preparation with povidone-iodine

Group Type ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type DRUG

preoperative skin preparation with scrub and paint technique

chlorhexidine-alcohol

preoperative skin preparation with scrub and paint technique

Group Type EXPERIMENTAL

chlorhexidine-alcohol

Intervention Type DRUG

Preoperative skin preparation with scrub and paint technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

chlorhexidine-alcohol

Preoperative skin preparation with scrub and paint technique

Intervention Type DRUG

Povidone-Iodine

preoperative skin preparation with scrub and paint technique

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Chloraprep Betadine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Michael E. DeBakey VA Medical Center

FED

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rabih Darouiche

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rabih O Darouiche, M.D.

Role: STUDY_CHAIR

Baylor College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Veterans Affairs Boston Healthcare System

West Roxbury, Massachusetts, United States

Site Status

Durham VA Medical Center

Durham, North Carolina, United States

Site Status

Ben Taub General Hospital

Houston, Texas, United States

Site Status

Michael E Debakey Medical Center

Houston, Texas, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Milwaukee VA Medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 20054046 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-14542

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.