Polarity Action in Electrical Stimulation Transcutaneous Donors for Treatment Areas Burned Patients

U

University of Sao Paulo

Status

Unknown

Conditions

Burn

Treatments

Other: Control Group
Device: Neuromuscular transcutaneous electrical stimulation (TENS)
Device: High voltage

Study type

Interventional

Funder types

Other

Identifiers

NCT02679703
8639

Details and patient eligibility

About

To evaluate the effect of the polarity of the electric current in healing.

Full description

The objective of this study is to evaluate the effect of the polarity of the current in healing. Both will be compared to the effects of electrical stimulation of high voltage (HVES) and neuromuscular transcutaneous electrical stimulation (TENS) in the treatment of donor sites (DA) of burn patients. It is a prospective, controlled clinical, randomized, blinded. Will be assessed 60 subjects aged 18-59 years, of both sexes, underwent the surgical procedure of grafting (PCE) were randomly divided into small blocks 5:5:5 three groups: undergoing therapeutic procedure with HVES undergoing therapeutic procedure with TENS and control. Therapeutic procedures will be applied around the DA, thigh or scalp, after 24 hours of PCE until complete healing. The variables will be the healing time estimated by the removal of the dressing rayon, clinical evaluation, scar quality, the Vancouver scale; pain, the pain numerical scale evaluation (PNS); blood perfusion by thermography; quality of healing by digital imaging, quantification of areas of crusts by the software Image J; skin biomechanical aspects as firmness, the durometer being performed reassessment at the end of treatment. Data will be submitted to analysis of normality by the Shapiro-Wilk test and the effect of behavior among groups and pre- and post-intervention will be evaluated by ANOVA-two way followed by post-hoc (Bonferroni) or Friedman, with p <0.05. Comparing groups, before a normal distribution is applied ANOVA followed by Tukey, and otherwise will be applied the Kruskal-Wallis test and post-hoc Dunn, p<0.05.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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).

Exclusion criteria

  • Diabetes,
  • Infectious processes
  • Use of medications that alter the healing process (corticosteroids, chemotherapy, radiotherapy, among others)
  • Cognitive impairment
  • Agreeing not to sign the Consent Form and Clarified or that do not fit the inclusion criteria described.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

High voltage
Experimental group
Description:
The 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.
Treatment:
Device: High voltage
Neuromuscular transcutaneous electrical stimulation (TENS)
Experimental group
Description:
10 Hz, 40 min, 200 μs and 25% above of motor level
Treatment:
Device: Neuromuscular transcutaneous electrical stimulation (TENS)
Control Group
Experimental group
Description:
There will be no intervention
Treatment:
Other: Control Group

Trial contacts and locations

0

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Central trial contact

Camila Carvalho; Elaine Guirro

Data sourced from clinicaltrials.gov

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