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Microcurrent for Healing Autogenous Skin Donor Sites

U

United States Army Institute of Surgical Research

Status

Completed

Conditions

Burns

Treatments

Device: Silverlon Wound Contact Dressing
Device: Microcurrent stimulator

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00558701
H-07-003
I.2007.128 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Microcurrent Stimulator + Silverlon
Active Comparator group
Description:
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.
Treatment:
Device: Silverlon Wound Contact Dressing
Device: Microcurrent stimulator
Silverlon alone
Sham Comparator group
Description:
Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)
Treatment:
Device: Silverlon Wound Contact Dressing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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