Clinical trial NCT04643223: Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars
Official title: Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars in Patients With Deep Burns: a Randomized Triple Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Hypertrophic Scar
Keywords: burns
therapeutic elastic bandaging
functional bandage
Kinesio adhesive tapes
hypertrophic scar
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial randomized triple blind sham controlled. An experimental group that will use the elastic bandage with seventy to ninety percent tension on the hypertrophic scar. It was a controlled sham that had used the elastic bandage without strain on the hypertrophic scar.
Primary purpose: OTHER

Brief summary: Burns can lead to lesions of total thickness, which extend the reticular layer of the dermis requiring a healing process, resulting in aesthetic problems, hypertrophic and functional scars that causes the patient a state of low esteem and social isolation. Elastic bandage - Kinesio tape - is a low cost therapeutic resource when compared to the compression mesh and silicone gel plates, commonly indicated for the conservative treatment of these scars. The compressive effect of the bandage on the hypertrophic scar tissue promotes the reduction of local vascularization and the realignment of the collagen fibers, resulting in the repair of the multidirectional mobility of the treated tissue. The aim of the study is to determine the effect of elastic bandage with tension on the inflammatory response of hypertrophic scars in patients with deep burns. It is a randomized, triple blind study. Patients aged 18-59 years with hypertrophic scars due to burns will be included, and those with scaling and open wounds in scar tissue will be included, pregnant women and patients who have previously used any therapeutic resource that may have altered the remodeling process of the hypertrophic scar. The bandage will be applied on the scar selected by lottery. The intervention group will receive the bandage with a tension around 70% and the group will control the same bandage without tension. This feature will be used for a period of three to four days. Initial and subsequent evaluations will be performed after 45 and 90 days. Primary outcome: analysis of the inflammatory response. Through immunohistochemistry and the histological evaluation of the organization pattern of collagen fibers. Secondary: aesthetic and functional evaluation of the hypertrophic scar through the Vancouver scale. The statistical analysis will be done by the researcher and his collaborators, in addition to the statistical one, using the statistical programs Epi-Info 3.5 and Medcalc. For categorical variables, where appropriate, use of the chi-square test of association and Fisher's exact test. Regarding the quantitative variables, the unpaired samples were Student's t-test and if the distribution is not normal, the Mann-Whitney test will be used.

Detailed description: Burns can lead to lesions of total thickness, which extend the reticular layer of the dermis requiring a repair process 1-2. This healing process, generally due to external and internal stimuli, causes scarring changes, among them, the hypertrophic scar 3-4. They develop about two months after the burn, occur more frequently in areas of high tension, preferably in the extensor faces of the joints or when they cross perpendicularly the lines of force of the skin. They exhibit scar tissue growth above the surface of the skin, respecting the limits of the original wound and are characterized by their reddish color, high stature, decreased flexibility and altered sensitivity 5-10. Patients with this type of scar can present stiffness in scar tissue, disfigurement, joint contractures, reduced range of motion, difficulties in daily functions and even psychological problems 11.

Mechanical strengths, when applied externally, can decrease the thickness of the epidermis, reduce the inflammatory response and promote a reorganization of the collagen fibers contained in the dermis, and thus improve the appearance of the vascularization and flexibility of the hypertrophic scar. Based on this principle, one of the therapeutic resources that can exert this external compressive effect is the elastic bandage - kinesio tape 12-13.

The use of elastic bandage - kinesio-taping is based on the principles of kinesiology and the self-healing ability of the organism. It takes advantage of the physical and mechanical properties of the bandage and the therapeutic action by the specific method of its application. Improving the appearance and perception of the scar, reducing functional limitations, thus repairing the patient's self-esteem 14-15.

Due to the few publications on the mechanism of action of elastic bandage, and its benefits, in the treatment of cicatricial sequelae due to burn. There was interest in seeking evidence that could support the mechanism of action of this therapeutic resource, and thus, a randomized, triple blind, controlled sham clinical trial was developed. It will be held at the Rehabilitation Center of the Governador Paulo Guerra Restoration Hospital (HR) located in Brazil and reference in the care of the burned patient. The study period will be from March 2018 to March 2020, with collection expected for June 2019 to November 2019.

The study population is the patients with hypertrophic scarring in the rehabilitation clinic of the HR. Patients will be picked up at the reception of this service, and they will be referred to the researcher responsible for the project. Once identified, the checklist of eligibility criteria and if eligible, patients will be invited by the researcher to participate in the study. In case of acceptance, the Informed Consent Form will be read aloud and if they agree to participate, they will sign it.

Those selected will be referred for initial clinical evaluation and other protocols that involve the study, among them, the selection of the scar, which will obey the inclusion criteria, and define the lesion treated with kinesio tape. In sequence, participants will be allocated randomly and stealthily through a computerized algorithm according to a table of sequential numbers from 1 to 30 using software R version 2.5.1. Generating the list of random allocation order, patients will use the letters A and B not knowing their meaning, being established only as treated with tension or without tension. Randomization is simple in two groups, the experimental or intervention group that will receive the kinesio tape with tension between seventy to ninety percent and the sham group with zero tension.

Patients will be referred for evaluation of the functional and aesthetic aspect of the hypertrophic scar, using as instrument of the Vancouver scale. In sequence will be taken to collect the scar material studied, through a biopsy performed at the Center for Treatment of Burns HR. After data collection, evaluation and biopsy, the treatment of patients is started. The therapeutic proposal will follow the routine of the service and the therapeutic protocol of the study common to all patients with cicatricial sequelae consisting of lubrication and massage of the scar and performing active free exercises and stretching for the limbs involved in the injury. It follows with the application of kinesio tape in the patients involved in the intervention and control groups.

Eligibility criteria: Inclusion Criteria:

* Hypertrophic scars resulting from deep burns located in the upper and lower limbs and the anterior and posterior trunk;

Exclusion Criteria:

* Scar tissue showing scaling, somatosensory changes (touch, pressure and pain) and open wounds
* Pregnant women

Primary outcomes:
measure: Histological pattern of the organization of the collagen fibers collected from the scar tissue (basal)
timeFrame: 0 day
measure: Histological pattern of the organization of the collagen fibers collected from the scar tissue (45o. day)
timeFrame: 45 days
measure: Histological pattern of the organization of the collagen fibers collected from the scar tissue (90o. day)
timeFrame: 90 days
Secondary outcomes:
measure: Inflammatory response through immunohistochemistry (basal)
timeFrame: 0 day
measure: Inflammatory response through immunohistochemistry (45o. day)
timeFrame: 45 days
measure: Inflammatory response through immunohistochemistry (90o. day)
timeFrame: 90 days
measure: vancouver scale scars (basal)
timeFrame: 0 day
measure: vancouver scale scars (45o. day)
timeFrame: 45 days
measure: vancouver scale scars (90o. day)
timeFrame: 90 days
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Alex Sandro Roland de Souza
state: Pernambuco
Study officials:
affiliation: Fernando Fiqueira IMI
name: Ana B Albuquerqu, master
role: STUDY_CHAIR
affiliation: Hospital da Restauração Governador Paulo Guerra - Hospital da Restauração
name: Cláudia F Lima, doctorate
role: STUDY_CHAIR
affiliation: Universidade Federal de Pernambuco - UFPE
name: Juliana N Maia, doctorate
role: STUDY_CHAIR
affiliation: Fundação Oswaldo Cruz - Instituto Aggeu Magalhães
name: Edlene L Ribeiro, doctorate
role: STUDY_CHAIR
References: