Microcurrent for Healing Autogenous Skin Donor Sites

Prospective, Randomized, Controlled Study of the Efficacy of a Silver-coated Nylon Dressing Plus Active or Sham Microcurrent for Healing Autogenous Skin Donor Sites

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Device: Microcurrent stimulator; Device: Silverlon Wound Contact Dressing

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • USAISR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Wound Healing	Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing	20 days

Collaborators and Investigators

• Sponsor: United States Army Institute of Surgical Research
• Collaborators: Samueli Institute for Information Biology
• Investigators: Principal Investigator: Leopoldo C Cancio, MD, United States Army Institute of Surgical Research

Publications and helpful links

General Publications

• Kauvar DS, Cancio LC, Wolf SE, Wade CE, Holcomb JB. Comparison of combat and non-combat burns from ongoing U.S. military operations. J Surg Res. 2006 May 15;132(2):195-200. doi: 10.1016/j.jss.2006.02.043. Epub 2006 Mar 31.
• Malin EW, Galin CM, Lairet KF, Huzar TF, Williams JF, Renz EM, Wolf SE, Cancio LC. Silver-coated nylon dressing plus active DC microcurrent for healing of autogenous skin donor sites. Ann Plast Surg. 2013 Nov;71(5):481-4. doi: 10.1097/SAP.0b013e31829d2311.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 13, 2007
• First Submitted That Met QC Criteria: November 13, 2007
• First Posted (Estimate): November 15, 2007

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: microcurrent; burns; healing; donor site
• Other Study ID Numbers: H-07-003; I.2007.128 (Other Identifier: BAMC IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO