Microcurrent for Healing Autogenous Skin Donor Sites

NCT ID: NCT00558701

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2013-10-31

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.

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Microcurrent stimulator

Intervention Type: DEVICE

Microcurrent stimulation from 15-50 microamps

Silverlon Wound Contact Dressing

Intervention Type: DEVICE

Silver coated nylon dressing FDA approved for use on donor sites in burn patients

Silverlon alone

Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)

Group Type: SHAM_COMPARATOR

Silverlon Wound Contact Dressing

Intervention Type: DEVICE

Silver coated nylon dressing FDA approved for use on donor sites in burn patients

Interventions

Microcurrent stimulator

Microcurrent stimulation from 15-50 microamps

Intervention Type: DEVICE

Silverlon Wound Contact Dressing

Silver coated nylon dressing FDA approved for use on donor sites in burn patients

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samueli Institute for Information Biology

OTHER

Sponsor Role: collaborator

United States Army Institute of Surgical Research

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leopoldo C Cancio, MD

Role: PRINCIPAL_INVESTIGATOR

United States Army Institute of Surgical Research

Locations

USAISR

Fort Sam Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16580688 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23903090 (View on PubMed)

Other Identifiers

I.2007.128

Identifier Type: OTHER

Identifier Source: secondary_id

H-07-003

Identifier Type: -

Identifier Source: org_study_id