Effect of Therapeutical Paraffin in the Malleability of Burned Skin

NCT03026270 | Unknown DMC

• 1 other identifier: 13386/2011
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Burn

Keywords

Physiotherapy; Paraffin; Burn; Contracture

Outcome Measures

Primary Outcomes (1)

• Distensibility of burned hypertrophic scar

  Will 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.

  up to 30 minutes

Secondary Outcomes (1)

• Hardness of burned hypertrophic scar before, immediately after 0, 10, 20 and 30 minutes.

  up to 30 minutes

Study Arms (2)

seven layers

OTHER

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)

Other: Paraffin

ten layers

OTHER

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)

Other: Paraffin

Interventions

Paraffin OTHER

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

seven layers; ten layers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Burns; Contracture

Interventions

Paraffin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Central Study Contacts

Elaine Guirro

CONTACT

55(16)3315-0215; ecguirro@fmrp.usp.br

Thais Amaral

CONTACT

55(16)3315-0215; thais.pescarolo.amaral@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor postgraduation Program in Rehabilitation and Functional Performance

Study Record Dates

• First Submitted: November 19, 2016
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 20, 2017

Record last verified: 2017-01