BurnNCT02679703
Polarity Action in Electrical Stimulation Transcutaneous Donors for Treatment Areas Burned Patients
A study testing High voltage and Neuromuscular transcutaneous electrical stimulation (TENS) in people with Burn, run by University of Sao Paulo.
Trial summary
To evaluate the effect of the polarity of the electric current in healing. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Burn
- What is being tested?
- High voltage and Neuromuscular transcutaneous electrical stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2016
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Victims of second deep degree and third degree burns, aged between 18 and 59 years
- Both sexes
- Underwent the surgical procedure of grafting (PCE) with donor area of the scalp or thigh thick standardized mean (0.20 mm).
Who cannot join
- Diabetes,
- Infectious processes
- Use of medications that alter the healing process (corticosteroids, chemotherapy, radiotherapy, among others)
- Cognitive impairment
- Agreeing not to sign the Consent Form and Clarified or that do not fit the inclusion criteria described.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Polarity Action in Electrical Stimulation Transcutaneous for Treatment of Graft Donor Areas in Patients Autogenous Burned: Blind Randomized Clinical Trial
To evaluate the effect of the polarity of the electric current in healing.
Read the detailed description
The objective of this study is to evaluate the effect of the polarity of the current in healing. Both will be compared to the effects of electrical stimulation of high voltage (HVES) and neuromuscular transcutaneous electrical stimulation (TENS) in the treatment of donor sites (DA) of burn patients. It is a prospective, controlled clinical, randomized, blinded. Will be assessed 60 subjects aged 18-59 years, of both sexes, underwent the surgical procedure of grafting (PCE) were randomly divided into small blocks 5:5:5 three groups: undergoing therapeutic procedure with HVES undergoing therapeutic procedure with TENS and control. Therapeutic procedures will be applied around the DA, thigh or scalp, after 24 hours of PCE until complete healing. The variables will be the healing time estimated by the removal of the dressing rayon, clinical evaluation, scar quality, the Vancouver scale; pain, the pain numerical scale evaluation (PNS); blood perfusion by thermography; quality of healing by digital imaging, quantification of areas of crusts by the software Image J; skin biomechanical aspects as firmness, the durometer being performed reassessment at the end of treatment. Data will be submitted to analysis of normality by the Shapiro-Wilk test and the effect of behavior among groups and pre- and post-intervention will be evaluated by ANOVA-two way followed by post-hoc (Bonferroni) or Friedman, with p <0.05. Comparing groups, before a normal distribution is applied ANOVA followed by Tukey, and otherwise will be applied the Kruskal-Wallis test and post-hoc Dunn, p<0.05.
- Conditions
- Burn
- Being tested
- High voltage, Neuromuscular transcutaneous electrical stimulation (TENS), Control Group
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High voltageDevice
Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns
Neuromuscular transcutaneous electrical stimulation (TENS)Device
Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns.
Control GroupOther
The control group will not have electrical stimulation however, will be evaluated with digital digital imaging, thermography imaging, skin hardness and subjective pain and healing scales
| Study group | Role | What they receive |
|---|---|---|
| High voltage | Experimental | The applied parameters of high voltage electrical stimulation are medium voltage of 100 volts, an increase in the course of the session, frequency of 10 Hz, with application in the donor areas of thigh or scalp for 40 minutes, 25% above of level engine daily until complete epithelialization, and removal of the dressing type rayon. Receives: Device: High voltage |
| Neuromuscular transcutaneous electrical stimulation (TENS) | Experimental | 10 Hz, 40 min, 200 μs and 25% above of motor level Receives: Device: Neuromuscular transcutaneous electrical stimulation (TENS) |
| Control Group | Experimental | There will be no intervention Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
We will count the time it takes days to remove the dressing rayon in donor areas.
Measured: One year
Secondary outcomes (1)
Numerical Pain Scale
we will evaluate the patient's pain before and after application of electro stimulation
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679703
- Sponsor's protocol ID
- 8639
- Status last verified
- Feb 2016
- First submitted
- 6 Feb 2016
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polarity Action in Electrical Stimulation Transcutaneous for Treatment of Graft Donor Areas in Patients Autogenous Burned: Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02679703
- Acronym / sponsor ID
- 8639
- Conditions
- Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Feb 2016 (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.
To evaluate the effect of the polarity of the electric current in healing.
Detailed description
The objective of this study is to evaluate the effect of the polarity of the current in healing. Both will be compared to the effects of electrical stimulation of high voltage (HVES) and neuromuscular transcutaneous electrical stimulation (TENS) in the treatment of donor sites (DA) of burn patients. It is a prospective, controlled clinical, randomized, blinded. Will be assessed 60 subjects aged 18-59 years, of both sexes, underwent the surgical procedure of grafting (PCE) were randomly divided into small blocks 5:5:5 three groups: undergoing therapeutic procedure with HVES undergoing therapeutic procedure with TENS and control. Therapeutic procedures will be applied around the DA, thigh or scalp, after 24 hours of PCE until complete healing. The variables will be the healing time estimated by the removal of the dressing rayon, clinical evaluation, scar quality, the Vancouver scale; pain, the pain numerical scale evaluation (PNS); blood perfusion by thermography; quality of healing by digital imaging, quantification of areas of crusts by the software Image J; skin biomechanical aspects as firmness, the durometer being performed reassessment at the end of treatment. Data will be submitted to analysis of normality by the Shapiro-Wilk test and the effect of behavior among groups and pre- and post-intervention will be evaluated by ANOVA-two way followed by post-hoc (Bonferroni) or Friedman, with p <0.05. Comparing groups, before a normal distribution is applied ANOVA followed by Tukey, and otherwise will be applied the Kruskal-Wallis test and post-hoc Dunn, p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High voltage | Experimental | Device: High voltageThe applied parameters of high voltage electrical stimulation are medium voltage of 100 volts, an increase in the course of the session, frequency of 10 Hz, with application in the donor areas of thigh or scalp for 40 minutes, 25% above of level engine daily until complete epithelialization, and removal of the dressing type rayon. |
| Neuromuscular transcutaneous electrical stimulation (TENS) | Experimental | Device: Neuromuscular transcutaneous electrical stimulation (TENS)10 Hz, 40 min, 200 μs and 25% above of motor level |
| Control Group | Experimental | Other: Control GroupThere will be no intervention |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Victims of second deep degree and third degree burns, aged between 18 and 59 years
- Both sexes
- Underwent the surgical procedure of grafting (PCE) with donor area of the scalp or thigh thick standardized mean (0.20 mm).
Key exclusion criteria (5 listed)
- Diabetes,
- Infectious processes
- Use of medications that alter the healing process (corticosteroids, chemotherapy, radiotherapy, among others)
- Cognitive impairment
- Agreeing not to sign the Consent Form and Clarified or that do not fit the inclusion criteria described.
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 |
|---|---|---|
| High voltageElectrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns | Device | High voltage |
| Neuromuscular transcutaneous electrical stimulation (TENS)Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns. | Device | Neuromuscular transcutaneous electrical stimulation (TENS) |
| Control GroupThe control group will not have electrical stimulation however, will be evaluated with digital digital imaging, thermography imaging, skin hardness and subjective pain and healing scales | Other | Control Group |
Primary outcome
Time
Time frame: One year
We will count the time it takes days to remove the dressing rayon in donor areas.
1 secondary outcome
Numerical Pain Scale
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing High voltage and Neuromuscular transcutaneous electrical stimulation (TENS) in people with Burn, run by University of Sao Paulo.
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 5 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 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Elaine Guirro (55(16)3315-0215, ecguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: One year). 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 10 Feb 2016.