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

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) Donor Sites in Adult Subjects

Conditions
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Split-thickness Skin Graft Donor Sites

Intervention / Treatment
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* Device: Opticell Ag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Opticell Ag dressing applied to STSG donor site
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opticell Ag<br>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. | Device: Opticell Ag<br>* Opticell Ag+ applied to STSG donor site<br>* Other names: Opticell Ag Plus Gelling Fiber with Silver;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 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. | Assessed up to 14 days of use | 
| Wound Healing Rate (Re-epithelialization) | 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. | Assessed up to 1 month postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing Quality | 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. | Assessed up to 1 month of use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Split-thickness skin graft, donor site, chitosan, dressing