The Use of Electrical Stimulation by Capacitive Field in the Repair of Skin Burns and Quality of Life

University of Sao Paulo

Status: Unknown

Conditions: Wound Healing; Burns

Treatments: Other: Electrical Stimulation by Capacitive Field Placebo Sham; Other: Electrical Stimulation by Capacitive Field

Study type: Interventional

Funder types: Other

Identifiers

NCT01882140

U1111-1143-4821

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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/2013.
• greater than 18 years.
• deep acute burn requiring excision and grafting

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Study Group

Experimental group

Description:

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.

Treatment:

Other: Electrical Stimulation by Capacitive Field

Control Group (Sham devices)

Placebo Comparator group

Description:

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.

Treatment:

Other: Electrical Stimulation by Capacitive Field Placebo Sham