Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) Donor Sites in Adult Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 19
- Primary Endpoint
- Wound Healing Rate (Re-epithelialization)
Study Overview
Brief Summary
The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressing).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inpatient status at study site
- •Subject must be receiving a split-thickness skin graft (STSG)
- •Wounds must not exceed 10% total body surface area (TBSA)
- •Any donor site
- •Ability to comply with necessary wound care/follow up
Exclusion Criteria
- •Subject is pregnant
- •Subject has been diagnosed with Diabetes
- •Subject is a smoker
- •Subject takes steroids
- •Subject is sensitive and/or allergic to shellfish and/or silver
- •Wounds that exceed 10% total body surface area (TBSA)
- •Inability to comply with necessary wound care/follow up
Arms & Interventions
Opticell Ag
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.
Intervention: Opticell Ag (Device)
Outcomes
Primary Outcomes
Wound Healing Rate (Re-epithelialization)
Time Frame: Assessed up to 1 month postoperatively.
The extent of re-epithelialization was evaluated by the surgeon and a blinded expert using photographs taken on days 10-14 and at 1 month postoperatively.
Pain
Time Frame: Assessed up to 14 days of use
Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity.
Secondary Outcomes
- Wound Healing Quality(Assessed up to 1 month of use)
Investigators
Indranil Sinha
Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery
Brigham and Women's Hospital