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临床试验/NCT01882140
NCT01882140Unknown不适用

The Use of Electrical Stimulation by Capacitive Field in the Repair of Skin Burns and Quality of Life: a Double-blind Randomized Controlled Clinical Trial

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
clinical evaluation of the lesion

研究概览

简要总结

The high incidence of burn injuries and mortality and morbidity as well as the high economic impact associated with this type of injury justifying the need to develop new technologies for the treatment of burn patients. Electrical stimulation for wound healing is a resource that has been increasingly used in routine physical therapists, but has the disadvantage of needing means of wet contact between the electrode and injury. The other resource used for therapeutic healing is conventional electrical stimulation of low intensity for capacitive field, a technique of physical therapy intervention not commercially available in Brazil. This new technology seems to have significant physiological effects in tissue repair and has been used for the treatment of chronic wounds which healed with difficulty. The objective is to analyze the effects of electrical stimulation of low intensity for capacitive field in healing skin burns. Patients from both genders aged over 18 years who have burns, will be evaluated and treated at the Emergency Unit of the Hospital of the Faculty of Medicine of Ribeirão Preto, University of São Paulo. The stimulation will be initiated within 24 hours after surgery to perform the graft and will be held daily for 60 minutes during the patient's stay or until complete healing of the skin. The electromagnetic field will be placed on the care of the burned area and / or the donor skin graft, not interfering with departmental procedures. Will be performed photographic record standardized wound by a digital camera, and then quantified by a computer program. Expected to reduce the period of hospitalization and thus lowering the cost of treatment, and the possibility of improving the quality of life of patients.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •all patients admitted to the Burns Unit of Clinical Hospital, Faculty of Medicine of Ribeirão Preto / USP, in the period between September 2014 and June/
  • •greater than 18 years.
  • •deep acute burn requiring excision and grafting

排除标准

  • •patients who use medicines that may interfere with the process of tissue repair.
  • •body mass index less than 16 kg / m²
  • •older than 65 years

研究组 & 干预措施

Study Group

Experimental

Patients in the Study Group will receive daily treatment for 60 minutes. The treatment is initiated within 24 hours following surgery to achieve graft. Use of Electrical Stimulation by Capacitive Field was the only addition to the current standard of care of the Emergency Unit of HC-FMRP/USP. These Electrical Stimulation by Capacitive Field devices do not produce heat or cause any sensation in tissue. The equipment will produce an electrical stimulation of low intensity pulsed output (1.5 MHz, 1:4 duty cycles, 30mW). The electrodes consist of two metal plates (20x20cm) separated by an insulating material.

干预措施: Electrical Stimulation by Capacitive Field (Other)

Control Group (Sham devices)

Placebo Comparator

Patients in the control group (Sham group) will receive the same treatment but the device remains off. Use of Electrical Stimulation by Capacitive Field was the only addition to the current standard of care of the Emergency Unit of HC-FMRP/USP.

干预措施: Electrical Stimulation by Capacitive Field Placebo Sham (Other)

结局指标

主要结局

clinical evaluation of the lesion

时间窗: Two years

The following parameters will be documented wound: wound appearance, capillarity, percentage of epithelialization, graft, signs of infection and sensitivity of the wound by burning to touch and clamping.

次要结局

  • standard photographs records of the wounds and quantified by ImageJ ® software(Two years)
  • quantification of wounds photographs by digital software(Two years)

研究者

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

Rinaldo Roberto de Jesus Guirro

PHD Professor

University of Sao Paulo

研究点 (1)

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