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Microcurrent for Healing Autogenous Skin Donor Sites

This study has been completed.
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00558701
First received: November 13, 2007
Last updated: April 26, 2016
Last verified: August 2015
  Purpose
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 Intervention
Burns
Device: Microcurrent stimulator
Device: Silverlon Wound Contact Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Time to Wound Healing [ Time Frame: 20 days ] [ Designated as safety issue: No ]
    Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing


Enrollment: 30
Study Start Date: December 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: November 13, 2007
Results First Received: August 21, 2015
Last Updated: April 26, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 26, 2016