Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects (STSG)
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|ClinicalTrials.gov Identifier: NCT02642679|
Recruitment Status : Completed
First Posted : December 30, 2015
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Split-thickness Skin Graft Donor Sites||Device: Opticell Ag||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Opticell Ag dressing applied to STSG donor site|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) Donor Sites in Adult Subjects|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||December 2016|
Experimental: 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.
Device: Opticell Ag
Opticell Ag+ applied to STSG donor site
- 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.
- 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.
- Wound Healing Quality [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642679
|Principal Investigator:||Indranil Sinha, MD||Brigham and Women's Hospital|