Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04643223 |
| Other study ID # |
U1111-1231-9216 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2014 |
| Est. completion date |
November 1, 2016 |
Study information
| Verified date |
November 2020 |
| Source |
Professor Fernando Figueira Integral Medicine Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
