Microcurrent for Healing Autogenous Skin Donor Sites

Burns Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00558701
• Other study ID #: H-07-003
• Secondary ID: I.2007.128
• Status: Active, not recruiting
• Phase: N/A
• First received: November 13, 2007
• Last updated: June 17, 2013
• Start date: December 2007
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Microcurrent with Silver Coated Dressing
Microcurrent stimulation from 15-50 microamps
• Silver coated dressing without active microcurrent
Silver coated dressing only

Locations

Country	Name	City	State
United States	USAISR	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research	Samueli Institute for Information Biology

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2006 Mar 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in donor site wound healing time of 2 days		12 days	No
Secondary	Reduce pain and infection		12 days	No