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Phase 3 N=849 Randomized Double-blind Prevention

Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Postoperative Wound Infection

Enrolled (actual)
849
Serious AEs
0.8%
Results posted
Aug 2014
Primary outcome: Primary: 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. — 16.1; 9.5 Percentage of Post Operative Infections — p=0.004

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
chlorhexidine-alcohol (Drug); Povidone-Iodine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Baylor College of Medicine
Primary completion
May 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
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.
16.1; 9.5 0.004 sig

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.

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 iodophors. -
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00290290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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