Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

Conditions
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Burns

Intervention / Treatment
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* Device: Silverlon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Device: Silverlon<br>* dressing for donor site mamagement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burns, donor site care, Silverlon dressing