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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02185950
Other study ID # U1111-1146-7342
Secondary ID
Status Recruiting
Phase N/A
First received August 15, 2013
Last updated July 9, 2014
Start date June 2012
Est. completion date March 2016

Study information

Verified date July 2014
Source University of Sao Paulo
Contact Elaine Guirro, PhD
Phone +551536024584
Email ecguirro@fmrp.usp.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Burning produces changes in the biomechanical properties of the skin causing limitation of movement. The increase in skin suppleness is very important in the rehabilitation process, since its increase makes therapeutic interventions aimed at increasing the range of motion, thus improving functional pattern. Will be evaluated 60 volunteers of both sexes aged 20-80 years seen at the Burns Unit of the Clinical Hospital of the Faculty of Medicine of Ribeirão Preto. There will be a traditional physical therapy evaluation as well as evaluation of the specific characteristics of the burn and scar. The temperature of the region will be assessed by thermography, and biophysical parameters and biomechanical skin evaluated by Cutometer and their accessory probes (mexameter, reviscometer, sebometer) before, immediately after and 10, 20 and 30 minutes of application of therapeutic resources. Volunteers will undergo continuous application of ultrasound with 3 MHz and intensity of 1 W/cm2 in the region due to scar deep second degree burn or third degree, and the application time of 2 minutes for each effective radiation area of the head (ERA) in a predetermined region of 9X5 cm a total of 4 minutes of application, therapy paraffin 20 minutes and 4 minutes endermology negative pressure between 100 and 200mmHg, in a continuous mode with glass head (1.5cm in diameter .) Applications will be set by random draw (design crusader cross-over) with an interval of 7 days between applications (wash-out). The data will be submitted to analysis of normality by the Shapiro-Wilk test, and the behavior of the effect between groups and pre-and post-intervention will be evaluated by two-way ANOVA followed by post-hoc (Bonferroni) or Friedman, p <0.05


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2016
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Victims of deep second degree burns and third degree with a length of at least 1% of body surface area burned

- Postoperative graft skin (4 and 6 months)

- Anywhere in the body that has area to uninjured contralateral control

- Good state of physical and mental health

- Aged between 20 and 80 years

- Both genders

- Irrespective of race, class or social group

Exclusion Criteria:

- Volunteers with illnesses or deformities that may interfere with evaluation and procedures

- Volunteers which do not accept signing the Instrument of Consent and do not meet the inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
ultrasound

paraffin

endermotherapy


Locations

Country Name City State
Brazil University of São Paulo RibeirãoPreto São paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Elasticity of skin and scar The measurement of skin and scar elasticity will be measured by the used a noninvasive assessment equipment, Cutometer. 3 years No
Secondary Erythema of skin and scar The measurement of skin and scar erythema will be measured by the probe accessory Cutometer, Mexameter. 3 years No
Secondary Fiber direction of skin and scar The measurement of skin and scar fiber direction will be measured by the probe accessory Cutometer, Reviscometer. 3 years No
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