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

NCT ID: NCT02642679

Last Updated: 2017-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Split-thickness Skin Graft Donor Sites

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Opticell Ag dressing applied to STSG donor site
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Opticell Ag

Intervention Type DEVICE

Opticell Ag+ applied to STSG donor site

Interventions

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Opticell Ag

Opticell Ag+ applied to STSG donor site

Intervention Type DEVICE

Other Intervention Names

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Opticell Ag+ Opticell Ag Plus Gelling Fiber with Silver

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medline Industries

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Indranil Sinha

Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Indranil Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Other Identifiers

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2015P001975

Identifier Type: -

Identifier Source: org_study_id