Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars

NCT04643223 | Completed DMC

• 1 other identifier: U1111-1231-9216
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Hypertrophic Scar

Keywords

burns; therapeutic elastic bandaging; functional bandage; Kinesio adhesive tapes; hypertrophic scar

Outcome Measures

Primary Outcomes (3)

• Histological pattern of the organization of the collagen fibers collected from the scar tissue (basal)

  the evaluations will only be carried out in a descriptive qualitative way, since the histology is characterized by analysis of the cells together with their cell matrix. Thus the organization of the collagen fibers will be described as being distributed in parallel to the reticular layer of the dermis, or may also be described as randomly distributed to the reticular layer of the dermis. Characterizing a variable of type yes/no.

  0 day

• Histological pattern of the organization of the collagen fibers collected from the scar tissue (45o. day)

  the evaluations will only be carried out in a descriptive qualitative way, since the histology is characterized by analysis of the cells together with their cell matrix. Thus the organization of the collagen fibers will be described as being distributed in parallel to the reticular layer of the dermis, or may also be described as randomly distributed to the reticular layer of the dermis. Characterizing a variable of type yes/no.

  45 days

• Histological pattern of the organization of the collagen fibers collected from the scar tissue (90o. day)

  the evaluations will only be carried out in a descriptive qualitative way, since the histology is characterized by analysis of the cells together with their cell matrix. Thus the organization of the collagen fibers will be described as being distributed in parallel to the reticular layer of the dermis, or may also be described as randomly distributed to the reticular layer of the dermis. Characterizing a variable of type yes/no.

  90 days

Secondary Outcomes (6)

• Inflammatory response through immunohistochemistry (basal)

  0 day

• Inflammatory response through immunohistochemistry (45o. day)

  45 days

• Inflammatory response through immunohistochemistry (90o. day)

  90 days

• vancouver scale scars (basal)

  0 day

• vancouver scale scars (45o. day)

  45 days

Study Arms (2)

Kinesio tape with tension

ACTIVE COMPARATOR

The intervention group will receive the elastic bandage - kinesio tape with tension between seventy to ninety percent on the selected hypertrophic scar. The application of kinesio tape follows a protocol, which involves the cleaning of the selected scar with liquid soap, drying, alcohol application for sebum removal, scar measurement and marking of the therapeutic zone and anchors. Following the application of the 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 Vancouver assessments and collections of scarring material for the histopathology will be carried out, in the time intervals corresponding to the beginning of the study intervention / entry (time 0), 45 days and 90 days after being eligible, to agree to participate in the study study and intervention.

Other: kinesio tape with tension

Kinesio tape without tension

SHAM COMPARATOR

The controlled sham group will receive the application of kinesio tape without tension will follow the same protocol above, including the three moments of evaluation, beginning of the intervention (time 0), 45 days and 90 days, after the beginning of the intervention.

Other: kinesio tape without tension

Interventions

kinesio tape with tension OTHER

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.

Also known as: Kinesio sport

Kinesio tape with tension

kinesio tape without tension OTHER

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.

Also known as: Kinesio sport

Kinesio tape without tension

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

Study Sites (1)

Alex Sandro Roland de Souza

Recife, Pernambuco, Brazil

Location

MeSH Terms

Conditions

Burns; Cicatrix, Hypertrophic

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Ana B Albuquerqu, master

  Fernando Fiqueira IMI

  STUDY CHAIR

• Cláudia F Lima, doctorate

  Hospital da Restauração Governador Paulo Guerra - Hospital da Restauração

  STUDY CHAIR

• Juliana N Maia, doctorate

  Universidade Federal de Pernambuco - UFPE

  STUDY CHAIR

• Edlene L Ribeiro, doctorate

  Fundação Oswaldo Cruz - Instituto Aggeu Magalhães

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This process will only be known to the researcher responsible for the project that will apply the kinesio tape on the scars; guaranteeing the concealment of the allocation with the triple masking, since the patients, the evaluators responsible for the Vancouver evaluation, the analysis of the histological and immunohistochemical material and the statistic will not be aware of this process.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of IMIP's Stricto Sensu Post-graduation; Prof. Adjunct of the Federal University of Pernambuco; Prof. of the Catholic University of Pernambuco (UNICAP)

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: November 25, 2020
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)