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

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

Interventions

OTHER

kinesio tape with tension

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.

OTHER

kinesio tape without tension

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.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute

  lead OTHER

Principal Investigators

• Ana B Albuquerqu, master · Fernando Fiqueira IMI

• Cláudia F Lima, doctorate · Hospital da Restauração Governador Paulo Guerra - Hospital da Restauração

• Juliana N Maia, doctorate · Universidade Federal de Pernambuco - UFPE

• Edlene L Ribeiro, doctorate · Fundação Oswaldo Cruz - Instituto Aggeu Magalhães

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-11-01

Primary Completion

2016-11-01

Completion

2016-11-01

Countries

• Brazil

Study Locations