Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation
Phase 1
Completed
- Conditions
- Surgery
- Interventions
- Drug: CHG
- Registration Number
- NCT02530528
- Lead Sponsor
- Medline Industries
- Brief Summary
Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).
- Detailed Description
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Healthy
- No dermatological conditions
Exclusion Criteria
- Sensitivity to CHG
- Sensitivity to natural latex rubber or adhesive skin products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2% CHG 1 min CHG single administration, 1 min application time 2% CHG 2 min CHG single administration, 2 min application time 2% CHG 3 min CHG single administration, 3 min application time Comparator 2% CHG CHG Single administration, Marketed CHG
- Primary Outcome Measures
Name Time Method Log Reduction of Bacterial Flora on Abdomen and Groin Sites 10 min, 6 hr and 8 hr Evaluate the Log Reduction of Normal Flora at various sites and timepoints
- Secondary Outcome Measures
Name Time Method