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

Burns Clinical Trial

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 Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01882140
• Other study ID #: U1111-1143-4821
• Status: Not yet recruiting
• Phase: N/A
• First received: May 28, 2013
• Last updated: June 17, 2013
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: June 2013
• Source: University of Sao Paulo
• Contact: Rinaldo Roberto Jesus Guirro, PHD
• Phone: +551636024584
• Email: rguirro[@]fmrp.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Wound Healing

Intervention

Other:
• Electrical Stimulation by Capacitive Field

• Electrical Stimulation by Capacitive Field Placebo Sham

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Two years	Yes
Secondary	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	Yes

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