Effectiveness of Kinesio Tex Tape Application in Reducing Edema and Seroma Formation Following Complex Reconstructive Breast Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in edema quantity at 30th postoperative day
研究概览
简要总结
Over the last two decades in the field of oncology, the prevention, diagnosis, treatment and rehabilitation have reached a remarkable development, improving healing rates and reducing the number of deaths from cancer. The most frequent cancer in the female population is the breast one, which consequences can become disabling. In recent years, surgeons need to find more effective and less invasive treatments. Nowadays, despite the achievements, oncological surgery can cause side effects that cannot allow the return to normal life. Some of these problems are represented by the formation of edema and seroma, which can be handled by the physiotherapist through the manual lymphatic drainage and the application of an elastic tape. The elastic tape is used a lot in clinical practice, despite it lacks supportive evidence.
The primary aim of the study is to verify the effectiveness of Kinesio Tex Tape in reducing edema and seroma formation following complex reconstructive breast surgery. The secondary goals are the evaluation of the quality of the scar, of the perception of pain, of the degree of satisfaction and disability.
It is a controlled, monocentric, national, comparative, randomized, single-blind study. The sample size is 60 patients who undergo complex reconstructive breast surgery. Patients are divided into two groups: the experimental one (receiving standard treatment and Kinesio Tex Tape application) and a group of control (just receiving standard treatment). To evaluate edema and seroma, ultrasound is used; ultrasounds will be on the 1st, 15th and 30th postoperative days (T0, T1 and T2); Vancouver Scar Scale is used to define the quality of the scar (T0 and T2); to measure the subjective perception of pain and to evaluate the degree of patient satisfaction, two VAS scales are administered (the VAS scale for pain is administered at T0, T1 and T2, while the VAS scale for satisfaction is given at T1 and T2); Finally, to assess the degree of disability, the DASH Questionnaire is used (T0, T1 and T2).
详细描述
Screening at the first evaluation:
The anamnesis for each potentially eligible patient will be performed to assess whether the inclusion and exclusion criteria are met.
If the selection criteria for inclusion in the study are met, the patient will be proposed to participate in the study with the delivery of the patient information sheet and the form will be delivered to obtain written and signed informed consent.
Only after having signed the signature on the form, the patient will in fact be eligible for the study.
Randomization assigns to each patient the treatment strategy assigned by the random process, as well as the numerical code that uniquely identifies the patient in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥ 18;
- •Complex reconstructive breast surgery with expander or prosthesis;
- •Conditions favoring the correct execution of the proposed program (ability to complete the questionnaires);
- •Written informed consent adherence.
排除标准
- •Patients with psychic or other disorders that may prevent the completion of the questionnaires and / or informed consent adherence;
- •Deferred breast reconstruction;
- •Bilateral breast surgery reconstruction;
- •Previous laterocervical emptying surgery;
- •Maintenance of the surgical drainage for more than 8 days;
- •Acute infections in other parts of the body.
结局指标
主要结局
Change in edema quantity at 30th postoperative day
时间窗: The measurement is assessed at 1st, 15th and 30th post-operative days.
Quantity of edema is measured in millimetres, through ultrasound scan. The verification of the effectiveness of elastic tape in terms of reduction of edema will be performed through ultrasound. During the ultrasound acquisition patients are indicated to assume the supine position on the couch, with 45 ° of humerus flexion and abduction, supported by an operator . Five points of maximum thickness of skin and subcutaneous tissue (edema) will be detected : retroareolar space, Upper-outer quadrant, Upper-inner quadrant, Lower-outer quadrant and Lower-inner quadrant. The thickness will be measured in millimeters.
Change in seroma quantity at 30th postoperative day
时间窗: The measurement is assessed at 15th and 30th post-operative days.
Quantity of seroma is measured in millimetres, through ultrasound scan. The verification of the effectiveness of elastic tape in terms of resolution of seroma will be performed through ultrasound. During the ultrasound acquisition patients are indicated to assume the supine position on the couch, with 45 ° of humerus flexion and abduction, supported by an operator . Five points of maximum thickness of liquid (seroma) will be detected : retroareolar space, Upper-outer quadrant, Upper-inner quadrant, Lower-outer quadrant and Lower-inner quadrant. The thickness will be measured in millimeters.
次要结局
- Degree of patient satisfaction(The measurement is assessed at 15th and 30th post-operative days.)
- Quality of the scar(The measurement is assessed at 1st and 30th post-operative days.)
- Subjective perception of pain(The measurement is assessed at 1st,15th and 30th post-operative days.)
- Degree of disability(The measurement is assessed at 1st, 15th and 30th post-operative days.)
研究者
Stefano Martella
Primary Doctor of General Reconstructive Surgery Operating Unit.
IRCCS San Raffaele