Clinical trial · Interventional
Local Compression Seroma DIminution Objective (CLODIS)
Interest of Local Compression by Thoracic Bandage on the Management of Seroma in Patients Treated by Mastectomy With or Without Lymphadenectomy. Local Compression Seroma DIminution Objective
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Surgical practices have evolved as surgeons practice immediate reconstructive surgery. We have not been able to meet the recruitment target.
Summary
Brief summary (as posted)
This study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. Half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.
Conditions
Conditions (3)
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 |
| Mastectomy | — | UNRESOLVED | — |
| Seroma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression by chest bandage urgo K2® | Device | — | UNRESOLVED |
| punctures | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Compression by chest bandage urgo K2®
- description
- After the second puncture, the local compression by thoracic bandage will be put in place. The system being effective 7 days, it will be left in place between each visit. A visit will be made for all patients 7 days after the installation of the device. However, if necessary, an intermediate visit may be carried out. During these visits, a puncture will be made according to the criteria mentioned above. The bandage will be renewed after each visit. The device will be removed after 15 days without indication of a new puncture. The patient will be seen again between 10 and 15 days after the bandage is removed for a final evaluation.
- interventionNames
- Device: Compression by chest bandage urgo K2®
- Procedure: punctures
- type
- ACTIVE_COMPARATOR
- label
- punctures
- description
- After the second puncture, the patient will be seen at the same frequency as in the experimental arm. The decision to perform a puncture will be made according to the same criteria and the follow-up conditions will be identical.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing. * Patient with a second seroma puncture with a volume greater than or equal to 250 ml. * Neo adjuvant chemotherapy authorized. * Absence of known metastases. * Patient has given written consent. Exclusion Criteria: * Mastectomy with immediate reconstruction. * Partial mastectomy. * Concurrent bilateral mastectomy. * Delay in healing observed at inclusion. * Patient under legal protection. * Chronic respiratory failure. * Patient with a pacemaker. * Personality disorders and known progressive psychiatric pathology. * Inability to submit to trial follow-up
References
Publications (0)
Data not yet available