The Effects of Therapeutic Resources on Structure and Function of Normal and Burned Skin

Burn Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02185950
• Other study ID #: U1111-1146-7342
• 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

• Burn
• Skin Graft

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

External Links

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