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

NCT02642679 | Completed Results DMC

• 1 other identifier: 2015P001975
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Split-thickness Skin Graft Donor Sites

Keywords

Split-thickness skin graft, donor site, chitosan, dressing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Wound Healing Quality

  Assessed up to 1 month of use

Study Arms (1)

Opticell Ag

EXPERIMENTAL

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

Interventions

Opticell Ag DEVICE

Opticell Ag+ applied to STSG donor site

Also known as: Opticell Ag+, Opticell Ag Plus Gelling Fiber with Silver

Opticell Ag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Medline Industries: collaborator

Limitations and Caveats

This pilot study is not a randomized, control study and is limited by the absence of a small sample size and direct comparison group.

Results Point of Contact

• Title: Indranil Sinha, MD
• Organization: Brigham and Women's Hospital

isinha@bwh.harvard.edu

617-732-5282

Study Officials

• Indranil Sinha, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery

Model Details: Opticell Ag dressing applied to STSG donor site

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 8, 2017
• Results First Posted: December 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share