Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

United States Army Institute of Surgical Research

Status

Completed

Conditions

Burns

Treatments

Device: Silverlon

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00137215

H-04-018

Details and patient eligibility

About

The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.

Hypothesis: The mean healing time for wounds treated with the Silverlon Dressing will be less than the mean healing time for wounds treated with Xeroform Dressing.

Full description

At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Silverlon dressing or Xeroform. The wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years or older; male or female.
Burn wounds of less than 30% total body surface area (TBSA) with no systemic abnormalities
Burns do not involve the harvesting area
Burn wounds require excision and grating of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
Scheduled excision and grafting procedures is the first such operation for subject during this hospitalization
Subject agrees to participate in follow-up evaluations

Exclusion criteria

Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep vein thrombosis (DVT) prophylaxis.
Cellulitis or other infection of potential donor site
Previously harvested donor site
Subject with greater than 30% TBSA burns
Subjects with sensitivity to silver or nylon
Pregnancy