Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects

Not Applicable

Completed

• Conditions: Split-thickness Skin Graft Donor Sites
• Interventions: Device: Opticell Ag

• Registration Number: NCT02642679
• Lead Sponsor: Brigham and Women's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-30
• Study Start: 2016-01
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Results First Submitted: 2017-09-02
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-05
• Last Update Submitted: 2017-11-05
• Results First Posted: 2017-12-08
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Opticell Ag	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.

Primary Outcome Measures

Name	Time	Method
Wound Healing Rate (Re-epithelialization)	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	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 Outcome Measures

Name	Time	Method
Wound Healing Quality	Assessed up to 1 month of use	Assessed using the Vancouver scar scale (VSS) 1-month post-operatively. The VSS is a widely used scale in clinical practice to document change in scar appearance. The scale scores four parameters: pigmentation, vascularity, pliability, and height for a total of 13 points. Normal appearance in each of the parameters garners a score of 0 and scores get higher (2-3) as an increase in parameters is observed. The lower the score, the better the outcome.