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

Burn Clinical Trial

Official title:

Polarity Action in Electrical Stimulation Transcutaneous for Treatment of Graft Donor Areas in Patients Autogenous Burned: Blind Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02679703
• Other study ID #: 8639
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2016
• Last updated: February 9, 2016
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: University of Sao Paulo
• Contact: Elaine Guirro
• Phone: 55(16)3315-0215
• Email: ecguirro[@]fmrp.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn

Intervention

Device:
• High voltage
Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns
• Neuromuscular transcutaneous electrical stimulation (TENS)
Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns.

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time	We will count the time it takes days to remove the dressing rayon in donor areas.	One year	No
Secondary	Numerical Pain Scale	we will evaluate the patient's pain before and after application of electro stimulation	One year	No