Clinical trial · Interventional
Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery
Effectiveness of Kinesio Tex Tape Application in Reducing Edema and Seroma Formation Following Complex Reconstructive Breast Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Implantation | — | UNRESOLVED | — |
| Edema | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
| Seroma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Kinesio tape lymphatic drainage technique application | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sperimental group
- description
- 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.
- interventionNames
- Device: Kinesio tape lymphatic drainage technique application
- type
- NO_INTERVENTION
- label
- Control group
- description
- 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.
Primary outcomes (2)
- measure
- Change in edema quantity at 30th postoperative day
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available