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Effect of Therapeutical Paraffin in the Malleability of Burned Skin

Effect of Therapeutical Paraffin Wax Bath in the Malleability of Burned Skin

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03026270
Enrollment
60
Registered
2017-01-20
Start date
2017-01-31
Completion date
2017-12-31
Last updated
2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

Keywords

Physiotherapy, Paraffin, Burn, Contracture

Brief summary

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

Detailed 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.

Interventions

The application of paraffin wax will be performed with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide), will spend several layers with the brush into two distinct groups, seven or ten layers depending on the outcome of randomisation, in the region of interest of the upper limb, being scarred, surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Distensibility of burned hypertrophic scarup to 30 minutesWill be evaluated through the Cutometer®-MPA 580 of the intervention with therapeutic paraffin, being constituted by a small probe with diameter of 4 mm coupled in the equipment. The mechanism of action consists of deformation of the skin caused by suction, ie negative pressure giving a measured value. Once applied to the skin, an infrared light and a sensor located inside the probe perform the measurement of the distension of the skin during the period of continuous suction, followed by the phase of off where there is no suction.

Secondary

MeasureTime frameDescription
Hardness of burned hypertrophic scar before, immediately after 0, 10, 20 and 30 minutes.up to 30 minutesThe instrument was used immediately after 0, 10, 20 and 30 minutes of therapeutic paraffin intervention, always in a position perpendicular to the surface of the skin to minimize errors due to the inclination of the device and repeated three times , To obtain an average of values, intervals for 10 seconds between evaluations (Klinger, et al., 2013)

Contacts

Primary ContactElaine Guirro
ecguirro@fmrp.usp.br55(16)3315-0215
Backup ContactThais Amaral
thais.pescarolo.amaral@usp.br55(16)3315-0215

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026