Evaluation of Dermafill Dressing for Donor Sites

This study has been completed.
Sponsor:
Information provided by:
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00137163
First received: August 25, 2005
Last updated: July 24, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Burns
Device: Dermafill Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Dermafill Dressing for Autogenous Skin Donor Sites

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • 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:
  • Infections associated with donor sites will be equal to or less with Dermafill as compared with Xeroform

Estimated Enrollment: 17
Study Start Date: March 2005
Study Completion Date: March 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00137163

Locations
United States, Texas
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234-6315
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Michael Albrecht, MD US Army Institute of Surgical Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00137163     History of Changes
Other Study ID Numbers: H-04-026
Study First Received: August 25, 2005
Last Updated: July 24, 2008
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
burns
donor site care
Dermafill dressing

ClinicalTrials.gov processed this record on October 19, 2014