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Microcurrent for Healing Autogenous Skin Donor Sites

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ClinicalTrials.gov Identifier: NCT00558701
Recruitment Status : Completed
First Posted : November 15, 2007
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Burns Device: Microcurrent stimulator Device: Silverlon Wound Contact Dressing Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled Study of the Efficacy of a Silver-coated Nylon Dressing Plus Active or Sham Microcurrent for Healing Autogenous Skin Donor Sites
Study Start Date : December 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Time to Wound Healing [ Time Frame: 20 days ]
    Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558701


Locations
United States, Texas
USAISR
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Samueli Institute for Information Biology
Investigators
Principal Investigator: Leopoldo C Cancio, MD United States Army Institute of Surgical Research

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00558701     History of Changes
Other Study ID Numbers: H-07-003
I.2007.128 ( Other Identifier: BAMC IRB )
First Posted: November 15, 2007    Key Record Dates
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016
Last Verified: August 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by United States Army Institute of Surgical Research:
burns
donor site
healing
microcurrent