Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars
Condition: Burns; Hypertrophic Scar
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional

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.
    

Intervention name(s): kinesio tape with tension; kinesio tape without tension
Intervention type(s): Other; Other
Intervention description(s): The application of kinesio tape follows a protocol, which involves the sanitization of the selected scar with liquid soap, drying and application of alcohol to remove sebum. Measurement of the scar and marking of the therapeutic zone and anchors. Following the application of kinesio tape, with tension between seventy to ninety percent on the treated hypertrophic scar. This process follows the routine of patient care established by the service and will continue for a period corresponding to three months. In which, the evaluations of Vancouver, the collections of cicatricial material will be carried out, in the time spaces corresponding to forty-five and ninety days, having as reference the initial evaluation made after being elected.; The application of kinesio tape without tension follows a protocol, which involves the sanitization of the selected scar with liquid soap, drying and application of alcohol to remove sebum. Measurement of the scar and marking of the therapeutic zone and anchors. Following application of the kinesio tape, no tension on the treated hypertrophic scar. This process follows the routine of patient care established by the service and will continue for a period corresponding to three months. In which, the evaluations of Vancouver, the collections of cicatricial material will be carried out, in the time spaces corresponding to forty-five and ninety days, having as reference the initial evaluation made after being elected.
Other intervention name(s): Kinesio sport; Kinesio sport
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: burns; therapeutic elastic bandaging; functional bandage; Kinesio adhesive tapes; hypertrophic scar