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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642679
First Posted: December 30, 2015
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medline Industries
Information provided by (Responsible Party):
Indranil Sinha, Brigham and Women's Hospital
  Purpose
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).

Condition Intervention
Split-thickness Skin Graft Donor Sites Device: Opticell Ag

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Opticell Ag dressing applied to STSG donor site
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) Donor Sites in Adult Subjects

Further study details as provided by Indranil Sinha, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 19
Actual Study Start Date: January 2016
Study Completion Date: December 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • Opticell Ag+
  • Opticell Ag Plus Gelling Fiber with Silver

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Brigham and Women's Hospital
Medline Industries
Investigators
Principal Investigator: Indranil Sinha, MD Brigham and Women's Hospital
  More Information

Responsible Party: Indranil Sinha, Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02642679     History of Changes
Other Study ID Numbers: 2015P001975
First Submitted: December 22, 2015
First Posted: December 30, 2015
Results First Submitted: September 2, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Indranil Sinha, Brigham and Women's Hospital:
Split-thickness skin graft, donor site, chitosan, dressing

Additional relevant MeSH terms:
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants