Clinical trial NCT03477565: Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery
Official title: Effectiveness of Kinesio Tex Tape Application in Reducing Edema and Seroma Formation Following Complex Reconstructive Breast Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Mastectomy
Breast Implantation
Edema
Seroma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: 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.

Once the randomization has been carried out, the following information will be collected at the moment before the tape application:

* Name and surname.
* Age.
* Profession.
* Type of surgical intervention.
* Side of the surgical intervention.
* Previous or concurrent diseases.
* Eventual adverse events.
* Thickness of skin and subcutaneous tissue, detected by ultrasound.
* Thickness of liquid, detected by ultrasound.
* Pain referred by the patient (VAS Scale).
* Patient satisfaction level (VAS Scale).
* Scar quality measured by the blind surgeon (Vancouver Scar Scale)
* Disability of the patient (DASH Questionnaire)

Screening for subsequent evaluations:

The following information will be collected:

* Thickness of skin and subcutaneous tissue (edema) and serum collection (seroma) detected by ultrasound.
* Quality of the scar measured by the blind surgeon (Vancouver Scar Scale).
* Subjective pain sensation (VAS Scale).
* Patient satisfaction level (VAS Scale).
* Disability of the patient (DASH Questionnaire).

Treatment:

Kinesio Tex Tape strips are applied to the patient in the experimental group following the technique of Dr. Kenzo Kase for lymphatic drainage. The choice of tape's length and of strips' number to be applied is based on the area of the breast edema and / or presence of seroma, which must be completely covered. The patch is cut into a fan strip: a length of kinesio tex tape is solid at one end and cut to create 4-6 narrow strips or tails. Corners are rounded to prevent detachment. The application area must be clean and dry. 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, which is created manually or by extending the structures involved. Tails are applied in parallel, with a small distance between them.The first application takes place on the 1st post-operative day, while the second is performed on the 7th post-operative day. In the event that the tape is detached from one application to another, it is necessary that the patient resume in the clinic for a new application, so as to ensure continuity of the therapeutic effect; otherwise, the patient is eliminated from the study. The experimental group also receives the expected standard treatment. By standard treatment we mean physiotherapeutic evaluation and physiotherapy counseling. The educational part, the demonstration of the exercises to be performed autonomously and the demonstration of prosthesis mobilization are included in this treatment.

Temporary or ultimately treatment interruption:

There are no conditions that allows to interrupt and then restart the study. If a subject decides to interrupt the study, the decision will be ultimate and a conclusion visit will be carried out in order to understand the drop out motivations; data will be analysed for intention-to-treat analysis.

• Statistics considerations

Sample size:

In order to assess the 1st co-primary endpoint (seroma resolution at 30 days) the percentages will be compared; from our clinical experience we except the 50% of subjects without tape will resolve seroma at 30 days, while 90% of subjects with kinesio-tape treatment will resolve at the same time.

In order to highlight this difference we will need to recruit 30 subjects per group with 2,5 % alpha error and 80% statistical power.

Regarding the 2nd co-primary endpoint (edema reduction), taking as reference the mean of five ultrasound breast acquisition, a size of 30 subjects in each group and a 80% statistical power will be required to determine a difference of 1.69 mm between null hypothesis which establishes the mean of both groups is 10.00 mm and alternative hypothesis establishing the 2nd group mean is 8.31 mm, taking a standard deviation of 2.00 mm for both groups.

• Statistics analysis

Demographics data and outcomes in the study will be analysed through descriptive statistics.

In case of Gaussian distribution, the continuous variables will be described through mean and standard deviation, while in case non-Gaussian distribution the continuous variables will be described through median and interquartile range. Categorical variables will be described through frequency percentages.

Considered variables' normal distribution will be verified through Shapiro-Wilk Test.

For the 1st co-primary endpoint (seroma resolution) at 30 days proportions will be compared, and in order to make the survival analysis seroma resolution times will be considered.

Curves will be estimated through Kaplan and Meier method and two groups comparison will be carried out through log-rank test.

For the 2nd co-primary endpoint (edema reduction) means at 30 days will be compared through repeated measures analysis of variance.

The analysis will be conducted through intention-to-treat population analysis, considering the two groups as randomized.

Also a confirmation analysis will be conducted on population who has correctly carried out the treatment (per-protocol population).

• Ethical and regulating considerations:

This clinical study will be conducted according to the main laws drawn up by the 18th World Medical Assembly (Helsinki, 1964) and to all the applicable amendments drawn up by World Medical Assembly, and to the ICH guide lines for Good Clinical Practice.

This clinical trial will conducted with reference to all international laws and regulations, and to national laws and regulations in force in the Nation where it is carried out, as well as to each applicable guide line.

• Informed consent:

The investigator, or a person appointed by him and under his responsibility, will inform exhaustively participants about all aspects pertaining to the clinical trial, according to all the applicable regulating dispositions.

All participants will be exhaustively informed about the study, using words and language they will be able to understand.

Before taking part to the clinical trial the subjects will have had signed the informed consent forms.

The patients will be told they will be able to drop out the study whenever they want, without any requested explanations, and that their decisions will not have any consequence.

Every informed consent will be included in the investigator's files. The patient will be given a dated and signed copy of informed consent.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in edema quantity at 30th postoperative day
timeFrame: The measurement is assessed at 1st, 15th and 30th post-operative days.
measure: Change in seroma quantity at 30th postoperative day
timeFrame: The measurement is assessed at 15th and 30th post-operative days.
Secondary outcomes:
measure: Quality of the scar
timeFrame: The measurement is assessed at 1st and 30th post-operative days.
measure: Subjective perception of pain
timeFrame: The measurement is assessed at 1st,15th and 30th post-operative days.
measure: Degree of patient satisfaction
timeFrame: The measurement is assessed at 15th and 30th post-operative days.
measure: Degree of disability
timeFrame: The measurement is assessed at 1st, 15th and 30th post-operative days.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCSSRaffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Stefano Martella
role: PRINCIPAL_INVESTIGATOR
References: