Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers
Phase 3
Completed
- Conditions
- Surgery
- Interventions
- Registration Number
- NCT02526667
- 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 Chlorhexidine Gluconate (CHG) application.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
Inclusion Criteria
- Males or Females
- 18 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 Active Chlorhexidine gluconate solution DynaHex-2 Dynahex 2% CHG Vehicle Cloth Vehicle Excipients on cloth Chlorhexidine Gluconate Cloth Chlorhexidine gluconate 2% CHG, single application
- Primary Outcome Measures
Name Time Method Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin 10 minutes, 6 hours, 8 hours Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bio High Tech SRL
🇷🇴Bucharest, Romania