Overview

This trial is active, not recruiting.

Condition burns
Treatments microcurrent with silver coated dressing, silver coated dressing without active microcurrent
Sponsor United States Army Institute of Surgical Research
Collaborator Samueli Institute for Information Biology
Start date December 2007
End date December 2010
Trial size 30 participants
Trial identifier NCT00558701, H-07-003, I.2007.128

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Use of the active microcurrent with the silver-coated dressing
microcurrent with silver coated dressing Silver Nylon dressing
Microcurrent stimulation from 15-50 microamps
(Sham Comparator)
Use a sham microcurrent with the silver coated dressing
silver coated dressing without active microcurrent Silver nylon dressing without microcurrent
Silver coated dressing only

Primary Outcomes

Measure
Decrease in donor site wound healing time of 2 days
time frame: 12 days

Secondary Outcomes

Measure
Reduce pain and infection
time frame: 12 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator Leopoldo C Cancio, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by United States Army Institute of Surgical Research.