Microcurrent for Healing Autogenous Skin Donor Sites
This trial is active, not recruiting.
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (outcomes assessor)|
Decrease in donor site wound healing time of 2 days
time frame: 12 days
Reduce pain and infection
time frame: 12 days
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
|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.|
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