Evaluation of Dermafill Dressing for Donor Sites
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJuly 28, 2008
July 1, 2008
1.8 years
August 25, 2005
July 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Infections associated with donor sites will be equal to or less with Dermafill as compared with Xeroform
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234-6315, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Albrecht, MD
US Army Institute of Surgical Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
March 1, 2005
Primary Completion
January 1, 2007
Study Completion
March 1, 2007
Last Updated
July 28, 2008
Record last verified: 2008-07