Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
- Conditions
- Post Surgical Incisions From Abdominoplasty Procedures
- Interventions
- Device: GLYDe Dressing
- Registration Number
- NCT00766727
- Lead Sponsor
- Neodyne Biosciences, Inc.
- Brief Summary
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
- Detailed Description
This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- subjects who have undergone an abdominoplasty 1 week prior to study participation
- subjects with a history of collagen vascular disease or scleroderma
- subjects with known adverse reactions to steri-strips, medical tapes or adhesives
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GLYDe Dressing GLYDe Dressing Investigational Dressing
- Primary Outcome Measures
Name Time Method Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control) through 12 months Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Josh Korman, MD
🇺🇸Mountain View, California, United States