Clinical trial NCT01882140: The Use of Electrical Stimulation by Capacitive Field in the Repair of Skin Burns and Quality of Life
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Wound Healing
Keywords: burns
wound healing
magnetic field therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: clinical evaluation of the lesion
timeFrame: Two years
Secondary outcomes:
measure: standard photographs records of the wounds and quantified by ImageJ ® software
timeFrame: Two years
measure: quantification of wounds photographs by digital software
timeFrame: Two years
Other outcomes:
measure: assessment of health status of burned patients
timeFrame: Two years
Locations:
city: Ribeirao Preto
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rinaldo Roberto de Jesus Guirro, PHD
role: PRINCIPAL_INVESTIGATOR
References: