Effect of Therapeutical Paraffin in the Malleability of Burned Skin

University of Sao Paulo

Status: Unknown

Conditions: Burn

Treatments: Other: Paraffin

Study type: Interventional

Funder types: Other

Identifiers

NCT03026270

13386/2011

Details and patient eligibility

About

Effect of therapeutical paraffin wax bath in the malleability of burned skin

Full description

The altered biomechanical properties of the skin entail limitation of movement, it have been important the statement of resources aimed at increasing skin suppleness. The objective of the study is to evaluate the effect of therapeutic paraffin in biophysical characteristics of the burned skin with or without scar hypertrophic. For this, 60 volunteers will be evaluated in the age group of 18-60 years, of both sexes, with deep second degree and third degree burns and evaluated areas submitted to therapeutic procedures, divided evenly into scar areas and normal skin. Applications will be set randomly by lot, with cross design (cross-over), and a minimum interval of seven days (wash-out) of the activities. The biophysical and biomechanical parameters of the skin will be assessed noninvasively by Cutometer of the model (MPA) 580, device to measure elasticity of the upper skin layer using negative pressure, and the durometer, measure hardness of the skin, before, immediately after 0, 10, 20 and 30 minutes of intervention with therapeutic paraffin in different procedures (number of layers and thermal insulation). Sociodemographic, clinical and surgical data of the volunteers will be evaluated by SPSS 15 (Statistical Analysis Software). The normality of the data will be verified by the Shapiro-Wilk test, and the effect of therapeutic procedures over time evaluated by the Friedman test (intragroup) and the test Kruskal-Wallis post hoc Dunn for comparisons between different funds (intergroup), p <0.05, will evaluated by software SPSS.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Will be included in the study individuals who were victims of 2 deep burns or 3rd grade being subjected to grafting autogenous procedures, with or without the presence of hypertrophic scar, normal skin of individuals, ie without tissue damage and to agree to sign the term free and informed consent.

Exclusion criteria

• They will be included in this study individuals with diseases or deformities that affect the structure and function of the skin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

seven layers

Other group

Description:

Volunteers will be submitted to the application of seven layers therapy paraffin surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded. .The Application will be made with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide)

Treatment:

Other: Paraffin

ten layers

Other group

Description:

Volunteers will be submitted to the application of seven layers therapy paraffin surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded. .The Application will be made with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide)

Treatment:

Other: Paraffin