Burns
Conditions
Keywords
burns, donor site care, Silverlon dressing
Brief summary
The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an 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 Silverlon Dressing will be less than the mean healing time for wounds treated with Xeroform Dressing.
Detailed description
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Silverlon dressing or Xeroform. The wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.
Interventions
DEVICESilverlon
dressing for donor site mamagement
Sponsors
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older; male or female. * Burn wounds of less than 30% total body surface area (TBSA) with no systemic abnormalities * Burns do not involve the harvesting area * Burn wounds require excision and grating of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas * Scheduled excision and grafting procedures 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 vein thrombosis (DVT) prophylaxis. * Cellulitis or other infection of potential donor site * Previously harvested donor site * Subject with greater than 30% TBSA burns * Subjects with sensitivity to silver or nylon * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform | 14 days |
| Cosmetic effect of healing at post operative day 30-45 will be equal to or less than with Silverlon as compared with Xeroform | 30-45 days |
Secondary
| Measure | Time frame |
|---|---|
| Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform | 14 days |
Countries
United States
Outcome results
None listed