Effect of Therapeutical Paraffin in the Malleability of Burned Skin

January 19, 2017 updated by: Elaine Caldeira de Oliveira Guirro, University of Sao Paulo

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: seven layers
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
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
Other: ten layers
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distensibility of burned hypertrophic scar
Time Frame: up to 30 minutes
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hardness of burned hypertrophic scar before, immediately after 0, 10, 20 and 30 minutes.
Time Frame: up to 30 minutes
The 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)
up to 30 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13386/2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings