Trial Outcomes & Findings for Microcurrent for Healing Autogenous Skin Donor Sites (NCT NCT00558701)

Results Overview

Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

20 days

Results posted on

2016-06-06

Participant milestones
Measure	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	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
Overall Study STARTED	15	15
Overall Study COMPLETED	14	11
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal
Measure	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	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
Overall Study Protocol Deviations	1	4

Microcurrent for Healing Autogenous Skin Donor Sites

Baseline characteristics by cohort
Measure	Microcurrent Stimulator + Silverlon n=14 Participants 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	Silverlon Alone n=11 Participants 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	Total n=25 Participants Total of all reporting groups
Age, Continuous	33.8 years STANDARD_DEVIATION 9.5 • n=5 Participants	33.8 years STANDARD_DEVIATION 9.5 • n=7 Participants	33.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants

Timeframe: 20 days

Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing

Outcome measures
Measure	Microcurrent Stimulator + Silverlon n=14 Participants 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	Silverlon Alone n=11 Participants 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
Time to Wound Healing	10.8 days Interval 7.0 to 15.0	11.1 days Interval 8.0 to 14.0

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Microcurrent Stimulator + Silverlon n=14 participants at risk 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	Silverlon Alone n=11 participants at risk 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
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.1% 1/14 • Number of events 1	0.00% 0/11
Vascular disorders Deep Vein Thrombosis (DVT)	0.00% 0/14	9.1% 1/11 • Number of events 1

Adverse event data not reported

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