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

NCT ID: NCT02185950

Last Updated: 2014-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Burn Skin Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ultrasound

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

paraffin

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

ultrasound

Intervention Type DEVICE

endermotherapy

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

paraffin

Intervention Type DEVICE

endermotherapy

Intervention Type DEVICE

Interventions

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ultrasound

Intervention Type DEVICE

paraffin

Intervention Type DEVICE

endermotherapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Elaine Caldeira de Oliveira Guirro

Professor, PT, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elaine Guirro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of São Paulo

RibeirãoPreto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Elaine Guirro, PhD

Role: CONTACT

+551536024584

Facility Contacts

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Elaine Guirro, PhD

Role: primary

+551636024584

Related Links

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Other Identifiers

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U1111-1146-7342

Identifier Type: -

Identifier Source: org_study_id

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