Clinical trial NCT00558701: Microcurrent for Healing Autogenous Skin Donor Sites
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: burns
donor site
healing
microcurrent
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
Collaborators: name: Samueli Institute for Information Biology
First posted: 2007-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to Wound Healing
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: USAISR
state: Texas
Study officials:
affiliation: United States Army Institute of Surgical Research
name: Leopoldo C Cancio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.