Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery

Summary

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).

Conditions

• Breast Cancer
• Mastectomy
• Breast Implantation
• Edema
• Seroma

Interventions

DEVICE

Kinesio tape lymphatic drainage technique application

Kinesio Tex Tape strips are applied following Dr.Kase draining techinique. The choice of tape's length and strips' number is based on the area of breast edema and/or presence of seroma, which must be completely covered. The patch is cut into fan strips. The major base is positioned near the functioning lymph node stations closest to the edema and/or seroma area. The bases and the tails of the fan must be applied with zero tension, while for the central part is reached 15-25% of tension. The first application takes place on the 1st post-operative day, while the second is performed on the 7th post-operative day. In case the tape is detached from one application to another, it is necessary that the patient resume in the clinic for a new application to ensure continuity of the therapeutic effect; otherwise the patient is eliminated from the study. The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and counselin.

Sponsors & Collaborators

• IRCCS San Raffaele

  lead OTHER

Principal Investigators

• Stefano Martella · IRCCS San Raffaele

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-03

Primary Completion

2020-04-01

Completion

2020-07-01

Countries

• Italy

Study Locations