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

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

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.

Study Overview

• Status: Unknown
• Conditions: Burns; Wound Healing
• Intervention / Treatment: Other: Electrical Stimulation by Capacitive Field; Other: Electrical Stimulation by Capacitive Field Placebo Sham

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rinaldo Roberto Jesus Guirro, PHD; Phone Number: Brazil +551636024584; Email: rguirro@fmrp.usp.br
• Study Contact Backup: Name: Laboratory of physiotherapy resources; Phone Number: +551636020462

Study Locations

• Brazil
  • Sao Paulo
    • Ribeirao Preto, Sao Paulo, Brazil, 14049-900
      • University of Sao Paulo
      • Contact: Rinaldo Roberto de Jesus Guirro, Ph.D; Phone Number: +551636024584; Email: rguirro@fmrp.usp.br
      • Principal Investigator: Rinaldo Roberto de Jesus Guirro, Ph. D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; 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.	Other: Electrical Stimulation by Capacitive Field
Placebo Comparator: Control Group (Sham devices); 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.	Other: Electrical Stimulation by Capacitive Field Placebo Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical evaluation of the lesion	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.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
standard photographs records of the wounds and quantified by ImageJ ® software	Will be held the photographic record standardized wound by a digital camera (resolution ≥ 6.0 Megapixel) and subsequently quantified by ImageJ ® software. Each image is calibrated by the tool "Analyze / Set Scale", which allows you to adjust the measure in pixels / cm through the rule contained in the photo. After this standardization selecting the plugin "Polygon" delimiting the border of the lesion with the mouse saving in extension ROI. Then the software automatically calculates the area in cm² (command <CTRL +M>).	Two years
quantification of wounds photographs by digital software	A computer software CaPAS - Carotid Plaque Analysis Software - will be used for the analysis of two-dimensional images scanned by statistical indexes of the first order (mean gray level and standard deviation) and second order (Entropy, Energy and Homogeneity).	Two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of health status of burned patients	For assessing the health status of burned patients will use a'' Burn Specific Health Scale-Revised'' (BSHS-R) in its version validated for the Portuguese of Brazil.	Two years

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Rinaldo Roberto de Jesus Guirro, PHD, University of Sao Paulo

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Estimate): June 20, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: burns; wound healing; magnetic field therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: U1111-1143-4821