Breast Cancer Clinical Trial
— BREASTAPEOfficial title:
Effectiveness of Kinesio Tex Tape Application in Reducing Edema and Seroma Formation Following Complex Reconstructive Breast Surgery
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).
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCSSRaffaele | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Quality of the scar | The surgeon will make the evaluation of the quality of the scar using the Vancouver Scar Scale. The scale includes the following subscales: Pigmentation (M) in which the best score is "0 = normal" and the worst is "2= Hyperpigmented" , Pliability (P) in which the best score is "0 = normal" and the worst "5 = contracture", Height (H) in which the best score is " 0 = flat" and the worst is "3 = > 5 mm" and Vascularity (V) in which the best score is "0 = normal" and the worst is "3 = purple. The subscales' scores are summed to compute a total score, where lower values represent a better quality of the scar. | The measurement is assessed at 1st and 30th post-operative days. | |
Secondary | Subjective perception of pain | The subjective perception of pain will be measured using Visual Analogue Scale for Pain. It is a measurement tool mainly used to indicate subjective pain characteristics. It consists of a strip of 10 cm in which its extremities correspond respectively to " 0 = no pain", "10 = worst pain that I can imagine", where lower values indicate a good subjective perception of pain. The health professional asks the patient to mark the pain perceived at that moment on the scale. | The measurement is assessed at 1st,15th and 30th post-operative days. | |
Secondary | Degree of patient satisfaction | The degree of patient satisfaction will be measured using Visual Analogue Scale. It consists of a strip of 10 cm in which its extremities correspond respectively to "0 = no satisfaction", "10 = maximum satisfaction", where higher values indicate a good degree of satisfaction. The health professional asks the patient to mark the satisfaction perceived at that moment on the scale. | The measurement is assessed at 15th and 30th post-operative days. | |
Secondary | Degree of disability | The degree of disability will be measured using DASH scale (The Disability of the Arm, Shoulder and Hand). It is a questionnaire concerning symptoms and abilities to perform certain activities that mainly require the use of the upper limb. For each subscale (30 items) the best score is "1 = no difficulty" and the worst is "5 = unable". The patient is asked to assign a score from 1 to 5 for each activity reported by referring only to the operated side. For the activities contraindicated by the surgeon patients are suggested to give score 5, "unable". On the 15th and 30th post-operative day the questions related to the activities of daily life refer to the past week, while on the 1st post-operative day the patients are required to consider the time passed since the intervention. The subscales' scores are summed to compute a total score, where lower values represent a lower degree of disability. |
The measurement is assessed at 1st, 15th and 30th post-operative days. |
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