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| Sponsors and Collaborators: |
Baylor College of Medicine Michael Debakey Veterans Affairs Medical Center Medical College of Wisconsin Department of Veterans Affairs |
|---|---|
| Information provided by: | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00290290 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Postoperative Wound Infection |
Drug: Chloraprep |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Chloraprep vs. Betadine for Prevention of Clean-Contaminated Surgical Wounds: A Prospective, Randomized, Multicenter Clinical Trial |
| Estimated Enrollment: | 1114 |
| Study Start Date: | September 2003 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 iodophores.
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Contacts and 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 | |
| Michael E Debakey Medical Center | |
| Houston, Texas, United States, 77030 | |
| Ben Taub General Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Milwaukee VA Medical Center | |
| Milwaukee, Wisconsin, United States, 53214 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53214 | |
| Study Chair: | Rabih O Darouiche, M.D. | Baylor College of Medicine |
More Information
| Responsible Party: | Baylor College of Medicine; Michael E. DeBakey VA Medical Center ( Rabih Darouiche, MD ) |
| Study ID Numbers: | H-14542 |
| Study First Received: | February 9, 2006 |
| Last Updated: | July 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00290290 |
| Health Authority: | United States: Institutional Review Board |
|
Prevention Antiseptic Preoperative Scrub Prevention Postoperative Wound Infection |
|
Chlorhexidine Postoperative Complications Chlorhexidine gluconate Wounds and Injuries |
Disorders of Environmental Origin Povidone-Iodine Surgical Wound Infection Wound Infection |
|
Anti-Infective Agents Anti-Infective Agents, Local Communicable Diseases Disinfectants Pathologic Processes |
Therapeutic Uses Infection Dermatologic Agents Pharmacologic Actions |
