The Use of Electrical Stimulation by Capacitive Field in the Repair of Skin Burns and Quality of Life
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJune 20, 2013
June 1, 2013
1.4 years
May 28, 2013
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
standard photographs records of the wounds and quantified by ImageJ ® software
Two years
quantification of wounds photographs by digital software
Two years
Other Outcomes (1)
assessment of health status of burned patients
Two years
Study Arms (2)
Study Group
EXPERIMENTALPatients 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.
Control Group (Sham devices)
PLACEBO COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rinaldo Roberto de Jesus Guirro, PHD
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD Professor
Study Record Dates
First Submitted
May 28, 2013
First Posted
June 20, 2013
Study Start
June 1, 2013
Primary Completion
November 1, 2014
Study Completion
February 1, 2015
Last Updated
June 20, 2013
Record last verified: 2013-06