Clinical trial · Interventional
Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy
Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy: Randomized, Controlled, Multicenter Clinical Study
- 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)
Aspirative drainage continues to be the "gold standard" for the management of this post-surgical complication, even though it can lead to complications such as obstruction of the drainage, peritubal leakage of the seroma, etc. This may result in pain and reduction in mobility of the affected arm. Based on our positive clinical outcomes and the fact that there is not any published data available in the literature regarding this use of the patch, the investigators propose a multicentric, randomized controlled clinical trial, with the objective of comparing the Hemopatch® with the usual technique used (aspirative drainage) in terms of efficacy and safety. Hypothesis: Placing a Hemopatch ® instead of an aspirative drainage in women after undergoing axillary lymph node dissection during breast cancer surgery may reduce the appearance of seroma and consequently the need for a puncture, as well as the complications related to aspirative drainage.
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 |
|---|---|---|---|
| Axillary Lymph Node Dissection | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast-conserving Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirative drainage | Procedure | — | UNRESOLVED |
| hemopatch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- aspirative drainage
- description
- Drainage is the usual treatment after axillary lymphadenectoma for breast cancer
- interventionNames
- Procedure: Aspirative drainage
- type
- ACTIVE_COMPARATOR
- label
- Hemopatch
- description
- The hemopatch group will be the group without drainage and with a product patch
- interventionNames
- Device: hemopatch
Primary outcomes (4)
- measure
- To develop seroma after surgery
- timeFrame
- Percentage, through study completion, an average of 2 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of breast cancer, * scheduled for surgical treatment including conservative surgery and ALND. * Signed informed consent for ALND. Exclusion Criteria: * Selective sentinel node biopsy negative. * Subsidiary mastectomy patients. * Denial of informed consent for axillary lymphadenectomy.
References
Publications (16)
- BACKGROUNDLewis KM, Ikeme S, Olubunmi T, Kuntze CE. Clinical effectiveness and versatility of a sealing hemostatic patch (HEMOPATCH) in multiple surgical specialties. Expert Rev Med Devices. 2018 May;15(5):367-376. doi: 10.1080/17434440.2018.1464909. Epub 2018 Apr 26. PMID 29658322
- BACKGROUNDDroeser RA, Frey DM, Oertli D, Kopelman D, Baas-Vrancken Peeters MJ, Giuliano AE, Dalberg K, Kallam R, Nordmann A. Volume-controlled vs no/short-term drainage after axillary lymph node dissection in breast cancer surgery: a meta-analysis. Breast. 2009 Apr;18(2):109-14. doi: 10.1016/j.breast.2009.02.003. Epub 2009 Mar 16. PMID 19289285
- BACKGROUNDAitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available. PMID 6359504
- BACKGROUNDKottayasamy Seenivasagam R, Gupta V, Singh G. Prevention of seroma formation after axillary dissection--a comparative randomized clinical trial of three methods. Breast J. 2013 Sep-Oct;19(5):478-84. doi: 10.1111/tbj.12164. Epub 2013 Jul 19. PMID 23865902
- BACKGROUNDWeber WP, Tausch C, Hayoz S, Fehr MK, Ribi K, Hawle H, Lupatsch JE, Matter-Walstra K, Chiesa F, Dedes KJ, Berclaz G, Lelievre L, Hess T, Guth U, Pioch V, Sarlos D, Leo C, Canonica C, Gabriel N, Zeindler J, Cassoly E, Andrieu C, Soysal SD, Ruhstaller T, Fehr PM, Knauer M; Swiss Group for Clinical Cancer Research (SAKK). Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial. Ann Surg Oncol. 2018 Sep;25(9):2632-2640. doi: 10.1245/s10434-018-6556-9. Epub 2018 Jun 8. PMID 29948418
- BACKGROUNDHe XD, Guo ZH, Tian JH, Yang KH, Xie XD. Whether drainage should be used after surgery for breast cancer? A systematic review of randomized controlled trials. Med Oncol. 2011 Dec;28 Suppl 1:S22-30. doi: 10.1007/s12032-010-9673-2. Epub 2010 Sep 9.