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临床试验/NCT02679703
NCT02679703Unknown不适用

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

University of Sao Paulo0 个研究点目标入组 60 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Time

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Time

时间窗: One year

We will count the time it takes days to remove the dressing rayon in donor areas.

次要结局

  • Numerical Pain Scale(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elaine Caldeira de Oliveira Guirro

Principal Investigator

University of Sao Paulo

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