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Microcurrent for Healing Autogenous Skin Donor Sites

This study is ongoing, but not recruiting participants.
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: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

A decrease in donor site wound healing time (as assessed by the research team) of 2 days will be observed with the addition of active microcurrent to silver- coated nylon dressing.


Condition Intervention
Burns
 Device: Microcurrent with Silver Coated Dressing
Device: Silver coated dressing without active microcurrent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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:

MedlinePlus related topics: Burns
U.S. FDA Resources

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

Primary Outcome Measures:
  • Decrease in donor site wound healing time of 2 days [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduce pain and infection [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Use of the active microcurrent with the silver-coated dressing
 Device: Microcurrent with Silver Coated Dressing
Microcurrent stimulation from 15-50 microamps
Other Name: Silver Nylon dressing
Sham Comparator: Group 2
Use a sham microcurrent with the silver coated dressing
 Device: Silver coated dressing without active microcurrent
Silver coated dressing only
Other Name: Silver nylon dressing without microcurrent

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). Secondary endpoints include pain and 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
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
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:

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
Last Updated: February 25, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 23, 2013