Polarity Action in Electrical Stimulation Transcutaneous Donors for Treatment Areas Burned Patients
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
To evaluate the effect of the polarity of the electric current in healing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 6, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 10, 2016
February 1, 2016
Same day
February 6, 2016
February 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time
We will count the time it takes days to remove the dressing rayon in donor areas.
One year
Secondary Outcomes (1)
Numerical Pain Scale
One year
Study Arms (3)
High voltage
EXPERIMENTALThe applied parameters of high voltage electrical stimulation are medium voltage of 100 volts, an increase in the course of the session, frequency of 10 Hz, with application in the donor areas of thigh or scalp for 40 minutes, 25% above of level engine daily until complete epithelialization, and removal of the dressing type rayon.
Neuromuscular transcutaneous electrical stimulation (TENS)
EXPERIMENTAL10 Hz, 40 min, 200 μs and 25% above of motor level
Control Group
EXPERIMENTALThere will be no intervention
Interventions
Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns
Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns.
The control group will not have electrical stimulation however, will be evaluated with digital digital imaging, thermography imaging, skin hardness and subjective pain and healing scales
Eligibility Criteria
You may qualify if:
- Victims of second deep degree and third degree burns, aged between 18 and 59 years
- Both sexes
- Underwent the surgical procedure of grafting (PCE) with donor area of the scalp or thigh thick standardized mean (0.20 mm).
You may not qualify if:
- Diabetes,
- Infectious processes
- Use of medications that alter the healing process (corticosteroids, chemotherapy, radiotherapy, among others)
- Cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 6, 2016
First Posted
February 10, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2016
Study Completion
December 1, 2016
Last Updated
February 10, 2016
Record last verified: 2016-02