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

Mass General Brigham

Status: Completed

Conditions: Split-thickness Skin Graft Donor Sites

Treatments: Device: Opticell Ag

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02642679

2015P001975

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Opticell Ag

Experimental group

Description:

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.

Treatment:

Device: Opticell Ag