Evaluation of Dermafill Dressing for Donor Sites

NCT ID: NCT00137163

Last Updated: 2008-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2007-03-31

Brief Summary

The purpose of the study is to compare one type of dressing against the current standard dressing that is used to cover the 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 Dermafill dressing will be less than the mean healing time for wounds treated with Xeroform dressing.

Detailed Description

At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. The donor sites will be harvested. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Dermafill dressing or Xeroform. The wound dressings will then be observed at least once a day beginning post op day 2/48hours after surgery until healed, which is defined as 90% or more of the wound surface is confluently re-epithelized.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Dermafill Dressing

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years or older; male or female.
• Burn wounds less than 30% of total body surface area (TBSA) with no systemic abnormalities
• Burns do not involve the harvesting area
• Burn wounds require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
• Scheduled excision and grafting procedure 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 venous thrombosis (DVT) prophylaxis.
• Cellulitis or other infection of potential donor site
• Previously harvested donor site
• Subjects with greater than 30% TBSA burns
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Army Institute of Surgical Research

FED

Sponsor Role: lead

Principal Investigators

Michael Albrecht, MD

Role: PRINCIPAL_INVESTIGATOR

US Army Institute of Surgical Research

Locations

US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Countries

United States

Other Identifiers

H-04-026

Identifier Type: -

Identifier Source: org_study_id