Evaluation of Dermafill Dressing for Donor Sites

Burns Clinical Trial

Official title:

Evaluation of Dermafill Dressing for Autogenous Skin Donor Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137163
• Other study ID #: H-04-026
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: July 24, 2008
• Start date: March 2005
• Est. completion date: March 2007

Study information

• Verified date: July 2008
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Dermafill Dressing

Locations

Country	Name	City	State
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain will be less or equal to with the Dermafill dressing as compared with Xeroform
Primary	Cosmetic effect of healing at post surgery day 30-60 will be equal or less with Dermafill as compared with Xeroform
Secondary	Infections associated with donor sites will be equal to or less with Dermafill as compared with Xeroform