BurnsNCT01882140
The Use of Electrical Stimulation by Capacitive Field in the Repair of Skin Burns and Quality of Life
A study testing Electrical Stimulation by Capacitive Field in people with Burns and Wound Healing, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Burns, Wound Healing
- What is being tested?
- Electrical Stimulation by Capacitive Field
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Laboratory of physiotherapy resources contact
Brazil1 site
University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900
Rinaldo Roberto de Jesus Guirro, Ph.D, +551636024584, rguirro@fmrp.usp.br
Rinaldo Roberto de Jesus Guirro, Ph. D
About this study
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
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.
- Conditions
- Burns, Wound Healing
- Being tested
- Electrical Stimulation by Capacitive Field, Electrical Stimulation by Capacitive Field Placebo Sham
- Keywords
- burns, wound healing, magnetic field therapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Stimulation by Capacitive FieldOther
Electrical Stimulation by Capacitive Field Placebo ShamOther
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 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. Receives: Other: Electrical Stimulation by Capacitive Field |
| Control Group (Sham devices) | Placebo comparator | 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. Receives: Other: Electrical Stimulation by Capacitive Field Placebo Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (2)
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 <CTRL +M>).
Measured: Two years
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).
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Rinaldo Roberto de Jesus Guirro, PHD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882140
- Sponsor's protocol ID
- U1111-1143-4821
- Status last verified
- Jun 2013
- First submitted
- 28 May 2013
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01882140
- Acronym / sponsor ID
- U1111-1143-4821
- Conditions
- Burns, Wound Healing
- Keywords
- burns, wound healing, magnetic field therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Electrical Stimulation by Capacitive FieldPatients 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 comparator | Other: Electrical Stimulation by Capacitive Field Placebo ShamPatients 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Stimulation by Capacitive Field | Other | Study Group |
| Electrical Stimulation by Capacitive Field Placebo Sham | Other | Control Group (Sham devices) |
Primary outcome
clinical evaluation of the lesion
Time frame: Two years
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.
2 secondary outcomes
standard photographs records of the wounds and quantified by ImageJ ® software
Time frame: Two years
quantification of wounds photographs by digital software
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laboratory of physiotherapy resources contact
Rinaldo Roberto de Jesus Guirro, PHD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation by Capacitive Field in people with Burns and Wound Healing, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rinaldo Roberto Jesus Guirro, PHD (+551636024584 ext. Brazil, rguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical evaluation of the lesion (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.