The Use of Electrical Stimulation by Capacitive Field in the Repair of Skin Burns and Quality of Life
Recruitment status was Not yet recruiting
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.
Other: Electrical Stimulation by Capacitive Field
Other: Electrical Stimulation by Capacitive Field Placebo Sham
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- clinical evaluation of the lesion [ Time Frame: Two years ] [ Designated as safety issue: Yes ]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.
- standard photographs records of the wounds and quantified by ImageJ ® software [ Time Frame: Two years ] [ Designated as safety issue: Yes ]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>).
- quantification of wounds photographs by digital software [ Time Frame: Two years ] [ Designated as safety issue: Yes ]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).
- assessment of health status of burned patients [ Time Frame: Two years ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882140
|Contact: Rinaldo Roberto Jesus Guirro, PHD||+551636024584 ext Brazilfirstname.lastname@example.org|
|Contact: Laboratory of physiotherapy resources||+551636020462|
|University of Sao Paulo||Not yet recruiting|
|Ribeirao Preto, Sao Paulo, Brazil, 14049-900|
|Contact: Rinaldo Roberto de Jesus Guirro, Ph.D +551636024584 email@example.com|
|Principal Investigator: Rinaldo Roberto de Jesus Guirro, Ph. D|
|Principal Investigator:||Rinaldo Roberto de Jesus Guirro, PHD||University of Sao Paulo|