Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars in Patients With Deep Burns: a Randomized Triple Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Histological pattern of the organization of the collagen fibers collected from the scar tissue (90o. day)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hypertrophic scars resulting from deep burns located in the upper and lower limbs and the anterior and posterior trunk;
排除标准
- •Scar tissue showing scaling, somatosensory changes (touch, pressure and pain) and open wounds
- •Pregnant women
研究组 & 干预措施
Kinesio tape without tension
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.
干预措施: kinesio tape without tension (Other)
Kinesio tape with tension
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.
干预措施: kinesio tape with tension (Other)
结局指标
主要结局
Histological pattern of the organization of the collagen fibers collected from the scar tissue (90o. day)
时间窗: 90 days
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.
Histological pattern of the organization of the collagen fibers collected from the scar tissue (45o. day)
时间窗: 45 days
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.
Histological pattern of the organization of the collagen fibers collected from the scar tissue (basal)
时间窗: 0 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.
次要结局
- Inflammatory response through immunohistochemistry (45o. day)(45 days)
- Inflammatory response through immunohistochemistry (90o. day)(90 days)
- Inflammatory response through immunohistochemistry (basal)(0 day)
- vancouver scale scars (basal)(0 day)
- vancouver scale scars (45o. day)(45 days)
- vancouver scale scars (90o. day)(90 days)
研究者
Alex Sandro Rolland de Souza
Prof. of IMIP's Stricto Sensu Post-graduation; Prof. Adjunct of the Federal University of Pernambuco; Prof. of the Catholic University of Pernambuco (UNICAP)
Professor Fernando Figueira Integral Medicine Institute