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

Split-thickness Skin Graft Donor Sites Clinical Trial

— STSG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642679
• Other study ID #: 2015P001975
• Status: Completed
• Phase: N/A
• First received: December 22, 2015
• Last updated: November 5, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Split-thickness Skin Graft Donor Sites

Intervention

Device:
• Opticell Ag
Opticell Ag+ applied to STSG donor site

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Medline Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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