Microcurrent for Healing Autogenous Skin Donor Sites

Study Overview
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Brief Summary
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This single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites.

Detailed Description
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The specific aims of the study are to evaluate the impact of active versus sham direct microcurrent application to silver nylon dressings in the treatment of donor sites for partial thickness thermal injuries. The primary endpoint is wound-closure time (re-epithelialization of 90% or more of wound surface). A secondary endpoint was infection. Exploratory assessments of clinical outcomes, including inflammation, and pain medication (type, dosage, route, timing) will also be conducted.

Official Title
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Prospective, Randomized, Controlled Study of the Efficacy of a Silver-coated Nylon Dressing Plus Active or Sham Microcurrent for Healing Autogenous Skin Donor Sites

Conditions
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Burns

Intervention / Treatment
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* Device: Microcurrent stimulator
* Device: Silverlon Wound Contact Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18-65 years of age burn less than 30% total body surface area burns not involving donor site area you need skin grafting to cover burns agree not to use other electronic devices that generate current during your study participation agree to come back for follow up visits at least every other day after discharge from hospital until donor site is healed Exclusion Criteria: you have an illness that may affect how your wound heals such as diabetes, blood clotting disorder, cirrhosis, liver failure, peripheral vascular disease you are taking medications that could affect how your wound heals such as steroids, Plavix, Coumadin you have an infection of the skin or your bloodstream you are pregnant or nursing you are sensitive or allergic to silver or nylon your burn wounds are more than 30% of your total body surface area your site was previously harvested for grafting you have an implantable pacemaker device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microcurrent Stimulator + Silverlon<br>Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator. | Device: Microcurrent stimulator<br>* Microcurrent stimulation from 15-50 microamps<br>Device: Silverlon Wound Contact Dressing<br>* Silver coated nylon dressing FDA approved for use on donor sites in burn patients<br>|
| Sham Comparator: Silverlon alone<br>Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation) | Device: Silverlon Wound Contact Dressing<br>* Silver coated nylon dressing FDA approved for use on donor sites in burn patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Wound Healing | Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burns, donor site, healing, microcurrent