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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01882140
First received: May 28, 2013
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Burns
Wound Healing
Other: Electrical Stimulation by Capacitive Field
Other: Electrical Stimulation by Capacitive Field Placebo Sham

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882140

Contacts
Contact: Rinaldo Roberto Jesus Guirro, PHD +551636024584 ext Brazil rguirro@fmrp.usp.br
Contact: Laboratory of physiotherapy resources +551636020462

Locations
Brazil
University of Sao Paulo Not yet recruiting
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Contact: Rinaldo Roberto de Jesus Guirro, Ph.D    +551636024584    rguirro@fmrp.usp.br   
Principal Investigator: Rinaldo Roberto de Jesus Guirro, Ph. D         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rinaldo Roberto de Jesus Guirro, PHD University of Sao Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Rinaldo Roberto de Jesus Guirro, PHD Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01882140     History of Changes
Other Study ID Numbers: U1111-1143-4821
Study First Received: May 28, 2013
Last Updated: June 17, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
burns
wound healing
magnetic field therapy

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014