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

NCT03477565 | Unknown

• 1 other identifier: TAP_Sett17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in edema quantity at 30th postoperative day

  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.

  The measurement is assessed at 1st, 15th and 30th post-operative days.

• Change in seroma quantity at 30th postoperative day

  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.

  The measurement is assessed at 15th and 30th post-operative days.

Secondary Outcomes (4)

• 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 patient satisfaction

  The measurement is assessed at 15th and 30th post-operative days.

• Degree of disability

  The measurement is assessed at 1st, 15th and 30th post-operative days.

Study Arms (2)

Sperimental group

EXPERIMENTAL

Patients who belong to the sperimental group ("SPER") will receive the standard treatment and Kinesio tape lymphatic drainage technique application. The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and physiotherapy counseling.

Device: Kinesio tape lymphatic drainage technique application

Control group

NO INTERVENTION

Patients who belong to the control group ("CONTR") will receive only the standard treatment. Standard treatment consists in physiotherapy evaluation and counseling. The educational part, the demonstration of the exercises and the prosthesis mobilization are included in this treatment.

Interventions

Kinesio tape lymphatic drainage technique application DEVICE

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.

Also known as: Kinesio Tape, Kinesiotape, Kinesio Tapes, Kinesio Taping, Kinesiology Taping

Sperimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCSSRaffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Edema; Seroma

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stefano Martella

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Martella

CONTACT

0226436622; martella.stefano@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Doctor of General Reconstructive Surgery Operating Unit.

Study Record Dates

• First Submitted: February 17, 2018
• First Posted: March 26, 2018
• Study Start: April 3, 2018
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 26, 2018

Record last verified: 2018-03

Locations

IT (1)