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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01882140
Enrollment
20
Registered
2013-06-20
Start date
2013-06-30
Completion date
2015-02-28
Last updated
2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Wound Healing

Keywords

burns, wound healing, magnetic field therapy

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.

Interventions

OTHERElectrical Stimulation by Capacitive Field
OTHERElectrical Stimulation by Capacitive Field Placebo Sham

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
clinical evaluation of the lesionTwo yearsThe 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

MeasureTime frameDescription
standard photographs records of the wounds and quantified by ImageJ ® softwareTwo yearsWill 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 softwareTwo yearsA 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

MeasureTime frameDescription
assessment of health status of burned patientsTwo yearsFor 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.

Countries

Brazil

Contacts

Primary ContactRinaldo Roberto Jesus Guirro, PHD
rguirro@fmrp.usp.br+551636024584
Backup ContactLaboratory of physiotherapy resources
+551636020462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026