The Use of Electrical Stimulation by Capacitive Field in the Repair of Skin Burns and Quality of Life
|ClinicalTrials.gov Identifier: NCT01882140|
Recruitment Status : Unknown
Verified June 2013 by Rinaldo Roberto de Jesus Guirro, University of Sao Paulo.
Recruitment status was: Not yet recruiting
First Posted : June 20, 2013
Last Update Posted : June 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Burns Wound Healing||Other: Electrical Stimulation by Capacitive Field Other: Electrical Stimulation by Capacitive Field Placebo Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||February 2015|
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
- clinical evaluation of the lesion [ Time Frame: 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.
- standard photographs records of the wounds and quantified by ImageJ ® software [ Time Frame: Two years ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|