Evaluation of Dermafill Dressing for Donor Sites

July 24, 2008 updated by: United States Army Institute of Surgical Research

Evaluation of Dermafill Dressing for Autogenous Skin Donor Sites

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234-6315
        • US Army Institute of Surgical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain will be less or equal to with the Dermafill dressing as compared with Xeroform
Cosmetic effect of healing at post surgery day 30-60 will be equal or less with Dermafill as compared with Xeroform

Secondary Outcome Measures

Outcome Measure
Infections associated with donor sites will be equal to or less with Dermafill as compared with Xeroform

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Army Institute of Surgical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

July 28, 2008

Last Update Submitted That Met QC Criteria

July 24, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-04-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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