Clinical trial · Interventional
Effectiveness of Compressive Bandage Use in Seroma Prevention
Effectiveness of Compressive Bandage Use in Post-Treatment Seroma Prevention Breast Cancer 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)
INTRODUCTION: Seroma is the most common complication after surgical treatment for breast cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. The therapeutic bandage has been inserted in clinical practice because it is similar to the elasticity of the skin and is able to help the circulatory and lymphatic system, reduce pain and local swelling, and may have benefits for prevention and treatment of seroma when applied compressively. . OBJECTIVE: To evaluate the effectiveness of compressive bandage in preventing seroma. METHODOLOGY: Randomized study of women over 18 years who underwent mastectomy at HCIII / INCA. Eligible patients will be allocated to the intervention and control groups by lot (270 envelopes, 135 patients per group). The intervention group, in addition to the use of the drain, will be submitted to the compression bandage on the day of hospital discharge and will be reevaluated on the seventh day. The control group will follow the institutional routine, using only the drain. The incidence and volume of the seroma, as well as the length of stay of the drain will be evaluated after 30 days through the medical record. Symptoms and skin changes resulting from the use of the bandage will be evaluated through a specific form. ANALYSIS: Descriptive analysis will be by measures of central tendency, dispersion and frequency distribution. Outcome assessment will be performed by odds ratio (for categorical variables) and by mean difference (Student's t-test), considering a 95% confidence interval. To control the confounding variables, multiple logistic regression (categorical outcome) and multiple linear regression (continuous outcome) will be performed by the Stepwise Forward method, including variables with p \<0.20.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Seroma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neuromuscular bandage | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Intervention group with preventive application of compressive bandages in addition to suction drain (routine adopted at the institution).
- interventionNames
- Device: neuromuscular bandage
- type
- NO_INTERVENTION
- label
- Group B
- description
- Group control. The patient will follow the institution's routine with only the suction drain.
Primary outcomes (3)
- measure
- Seroma Incidence
- timeFrame
- 30 days
- description
- the presence of assessed local fluctuation will be considered seroma by the nursing team during dressing care, with indication of puncture aspiration to resolve the condition, regardless of the volume drained.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 and over * underwent mastectomy assurgical treatment for breast cancer. Exclusion Criteria: * bilateral breast cancer; * patient undergoing neoadjuvant radiotherapy; * infection in the surgical wound or hematoma; * autoimmune disease reporting (dermatomyositis, hidradenitis suppurativa, nephropathy, lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma); * patients with difficulties in understanding.
References
Publications (2)
- DERIVEDFabro EAN, Costa RM, Fernandes MC, Ximenes MA, Nogueira DA, Soares NB, Thuler LCS, Bergmann A. Seroma incidence and risk factors in women undergoing mastectomies as surgical breast cancer treatment. Support Care Cancer. 2024 Sep 25;32(10):688. doi: 10.1007/s00520-024-08881-w. PMID 39322817
- DERIVEDFernandes MC, Fabro EAN, Ximenes MA, Costa RMM, Soares NB, Aguiar SS, Thuler LCS, Bergmann A. Compressive taping to prevent postmastectomy seroma: patient adherence and satisfaction. BMJ Support Palliat Care. 2024 May 17:spcare-2024-004912. doi: 10.1136/spcare-2024-004912. Online ahead of print. PMID 38760081