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

November 5, 2017 updated by: Indranil Sinha, Brigham and Women's Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed up to 14 days of use
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.
Assessed up to 1 month postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed up to 1 month of use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Medline Industries

Investigators

  • Principal Investigator: Indranil Sinha, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 28, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

December 8, 2017

Last Update Submitted That Met QC Criteria

November 5, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015P001975

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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