Polarity Action in Electrical Stimulation Transcutaneous... | NCT02679703

Studies
Polarity Action in Electrical Stimulation Transcutaneous Donors for Treatment Areas Burned Patients

NCT02679703

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Feb 10, 2016Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Burn

Interventions

High voltage
Neuromuscular transcutaneous electrical stimulation (TENS)
Control Group

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Feb 2016Actual

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 6, 2016

First Submission Date that Met QC Criteria

Feb 9, 2016

First Posted Date

Feb 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2016

Last Update Posted Date

Feb 10, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elaine Caldeira de Oliveira Guirro, Principal Investigator, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: High voltage
Neuromuscular transcutaneous electrical stimulation (TENS)	Experimental	10 Hz, 40 min, 200 μs and 25% above of motor level	Device: Neuromuscular transcutaneous electrical stimulation (TENS)
Control Group	Experimental	There will be no intervention	Other: Control Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High voltage	Device	Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns	High voltage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time	We will count the time it takes days to remove the dressing rayon in donor areas.	One year

Secondary Outcomes

Measure	Description	Time Frame
Numerical Pain Scale	we will evaluate the patient's pain before and after application of electro stimulation	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elaine Guirro	Contact	55(16)3315-0215		ecguirro@fmrp.usp.br
Camila Carvalho	Contact	55(16)3315-0215		camila.silva.carvalho@usp.br

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D004561	Transcutaneous Electric Nerve Stimulation
D035061	Control Groups

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided