Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects
Phase 3
Completed
- Conditions
- Surgery
- Interventions
- Registration Number
- NCT02222896
- Lead Sponsor
- Medline Industries
- Brief Summary
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.
- Detailed Description
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 347
Inclusion Criteria
- Males or Females
- 16 years of age or older
- Signed informed consent
- Good Health
- Six inches of abdomen and groin areas without tattoos, or skin disorders
Exclusion Criteria
- Dermatological Conditions
- Sensitivity to latex
- Sensitivity to CHG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Cloth Vehicle Excipients on cloth Active Chlorhexidine gluconate solution DynaHex-2 Dynahex 2% CHG Chlorhexidine Gluconate Cloth Chlorhexidine Gluconate 2% CHG, single application
- Primary Outcome Measures
Name Time Method Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin 10 minutes, 6 hours, 8 hours Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline.
Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MBT
🇺🇸Sterling, Virginia, United States