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

July 9, 2014 updated by: Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São paulo
      • RibeirãoPreto, São paulo, Brazil, 14049-900
        • Recruiting
        • University of Sao Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound group
Therapeutic ultrasound, 3 MHz, continuous with intensity 1W/cm2 will be applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) with exposure time of 2 minutes for each effective radiation area head (ERA), a total of 4 minutes of application in an area of 9X5 cm, and the application parameters with a matched control side of the patient, in a region with contralateral uninjured skin.
Device: ultrasound
Experimental: Group paraffin
Paraffin therapy is heated with thermostat own equipment, being applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) and control (uninjured), with a length of 9X5 cm, at a temperature of 38 ° C with appropriate brush in layers (4 layers), remaining for 20 minutes. After the period of application of paraffin will be removed and discarded, with no reuse.
Device: paraffin
Experimental: Ultrasound group + endermotherapy
Therapeutic ultrasound, 3 MHz, continuous with intensity 1W/cm2 will be applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) with exposure time of 2 minutes for each effective radiation area head (ERA), a total of 4 minutes of application in an area of 9X5 cm. The application of endermotherapy will be held shortly after the therapeutic ultrasound in a timely manner across the surface of the scar, for about 2 seconds per head area with a negative pressure between 100-200 mmHg, a total of 4 minutes application in an area of 9 x 5 cm. The same application parameters will be performed with one hand matched control patient, in a region with contralateral uninjured skin.
Device: ultrasound
Device: endermotherapy
Experimental: Group paraffin + endermotherapy
Paraffin therapy is heated with thermostat own equipment, being applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) and control (uninjured), with a length of 9X5 cm, at a temperature of 38 ° C with appropriate brush in layers (4 layers), remaining for 20 minutes. After the period of application of paraffin will be removed and discarded, with no reuse.The application of endermotherapy will be held shortly after the paraffin therapy in a timely manner across the surface of the scar, for about 2 seconds per head area with a negative pressure between 100-200 mmHg, a total of 4 minutes application in an area of 9 x 5 cm. The same application parameters will be performed with one hand matched control patient, in a region with contralateral uninjured skin.
Device: paraffin
Device: endermotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elasticity of skin and scar
Time Frame: 3 years
The measurement of skin and scar elasticity will be measured by the used a noninvasive assessment equipment, Cutometer.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythema of skin and scar
Time Frame: 3 years
The measurement of skin and scar erythema will be measured by the probe accessory Cutometer, Mexameter.
3 years
Fiber direction of skin and scar
Time Frame: 3 years
The measurement of skin and scar fiber direction will be measured by the probe accessory Cutometer, Reviscometer.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Elaine Guirro, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • U1111-1146-7342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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