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Microcurrent for Healing Autogenous Skin Donor Sites

Not Applicable
Completed
Conditions
Burns
Interventions
Device: Microcurrent stimulator
Device: Silverlon Wound Contact Dressing
Registration Number
NCT00558701
Lead Sponsor
United States Army Institute of Surgical Research
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Microcurrent Stimulator + SilverlonMicrocurrent stimulatorPatients 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.
Silverlon aloneSilverlon Wound Contact DressingPatients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)
Microcurrent Stimulator + SilverlonSilverlon Wound Contact DressingPatients 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.
Primary Outcome Measures
NameTimeMethod
Time to Wound Healing20 days

Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

USAISR

🇺🇸

Fort Sam Houston, Texas, United States

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