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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02679703
Enrollment
60
Registered
2016-02-10
Start date
2016-02-29
Completion date
2016-12-31
Last updated
2016-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

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.

Interventions

DEVICEHigh voltage

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

DEVICENeuromuscular transcutaneous electrical stimulation (TENS)

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

OTHERControl 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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
TimeOne yearWe will count the time it takes days to remove the dressing rayon in donor areas.

Secondary

MeasureTime frameDescription
Numerical Pain ScaleOne yearwe will evaluate the patient's pain before and after application of electro stimulation

Contacts

Primary ContactElaine Guirro
ecguirro@fmrp.usp.br55(16)3315-0215
Backup ContactCamila Carvalho
camila.silva.carvalho@usp.br55(16)3315-0215

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026