Burns
Conditions
Keywords
burns, donor site, healing, microcurrent
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.
Interventions
DEVICEMicrocurrent stimulator
Microcurrent stimulation from 15-50 microamps
DEVICESilverlon Wound Contact Dressing
Silver coated nylon dressing FDA approved for use on donor sites in burn patients
Sponsors
Samueli Institute for Information Biology
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Wound Healing | 20 days | Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients | 14 |
| Silverlon Alone Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)
Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients | 11 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Deviations | 1 | 4 |
Baseline characteristics
| Characteristic | Microcurrent Stimulator + Silverlon | Silverlon Alone | Total |
|---|---|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 9.5 | 33.8 years STANDARD_DEVIATION 9.5 | 33.8 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 11 |
| serious Total, serious adverse events | 1 / 14 | 1 / 11 |
Outcome results
Primary
Time to Wound Healing
Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing
Time frame: 20 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Microcurrent Stimulator + Silverlon | Time to Wound Healing | 10.8 days |
| Silverlon Alone | Time to Wound Healing | 11.1 days |