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

NCT ID: NCT02679703

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-12-31

Brief Summary

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

Detailed 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.

Conditions

Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High voltage

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.

Group Type: EXPERIMENTAL

High voltage

Intervention Type: DEVICE

Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns

Neuromuscular transcutaneous electrical stimulation (TENS)

10 Hz, 40 min, 200 μs and 25% above of motor level

Group Type: EXPERIMENTAL

Neuromuscular transcutaneous electrical stimulation (TENS)

Intervention Type: DEVICE

Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns.

Control Group

There will be no intervention

Group Type: EXPERIMENTAL

Control Group

Intervention Type: OTHER

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

Interventions

High voltage

Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns

Intervention Type: DEVICE

Neuromuscular transcutaneous electrical stimulation (TENS)

Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns.

Intervention Type: DEVICE

Control Group

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Elaine Caldeira de Oliveira Guirro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Elaine Guirro

Role: CONTACT

ecguirro@fmrp.usp.br

55(16)3315-0215

Camila Carvalho

Role: CONTACT

camila.silva.carvalho@usp.br

55(16)3315-0215

Other Identifiers

8639

Identifier Type: -

Identifier Source: org_study_id