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Completed

NCT Number: NCT00137163

Evaluation of Dermafill Dressing for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234-6315, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermafill Dressing

Device

Primary outcomes

  1. Pain will be less or equal to with the Dermafill dressing as compared with Xeroform

  2. Cosmetic effect of healing at post surgery day 30-60 will be equal or less with Dermafill as compared with Xeroform

Secondary outcomes

  1. Infections associated with donor sites will be equal to or less with Dermafill as compared with Xeroform

Sponsors and collaborators

Lead sponsor

United States Army Institute of Surgical Research

Fed

Registry information

Official study title

Evaluation of Dermafill Dressing for Autogenous Skin Donor Sites

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 29, 2005
Registry last updated
Jul 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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