Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy

NCT04487561 | Completed

• 1 other identifier: REDHEMOPACH
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Breast-conserving Surgery; Axillary Lymph Node Dissection

Keywords

aspirative drainage; hemopatch; seroma; breast cancer

Outcome Measures

Primary Outcomes (4)

• To develop seroma after surgery

  Percentage of patients that receive Hemopatch® that develop seroma after surgery and percentage of patients that receive that develop seroma after extraction of the aspirative drainage.

  Percentage, through study completion, an average of 2 months

• total volumen of the seroma

  The initial control will be performed 24 hours after the intervention, maintaining AD if the volume is greater than 30ml. All patients will be seen 7 days after surgery. The follow-up time will be weekly until there is no seroma, measuring the volume of the seroma extracted by puncture,

  from 24 hours until there is no seroma, assessed up to 2 months

• Seroma punctures

  the total number of punctures needed

  through study completion, an average of 2 months

• complications

  Other complications collected throughout the study include: bruising (yes / no), pain (yes / no), problems with aspiration drainage (yes / no)

  from 24 hours until there is no complications, assessed up to 2 months

Secondary Outcomes (3)

• quality of life in patients

  1 week after surgery with Eortc QLQ-BR23

• the costs

  through study completion, an average of 1 year

• body mass index

  weight (kg) / height (m2). In the first consultation

Study Arms (2)

aspirative drainage

OTHER

Drainage is the usual treatment after axillary lymphadenectoma for breast cancer

Procedure: Aspirative drainage

Hemopatch

ACTIVE COMPARATOR

The hemopatch group will be the group without drainage and with a product patch

Device: hemopatch

Interventions

hemopatch DEVICE

The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma

Hemopatch

Aspirative drainage PROCEDURE

The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma

aspirative drainage

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of breast cancer,
• scheduled for surgical treatment including conservative surgery and ALND.
• Signed informed consent for ALND.

You may not qualify if:

• Selective sentinel node biopsy negative.
• Subsidiary mastectomy patients.
• Denial of informed consent for axillary lymphadenectomy.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (16)

• Lewis 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 BACKGROUND

• Droeser 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 BACKGROUND

• Aitken 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 BACKGROUND

• Kottayasamy 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 BACKGROUND

• Weber 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 BACKGROUND

• He 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.

  PMID: 20827578 BACKGROUND

• Thomson DR, Sadideen H, Furniss D. Wound drainage after axillary dissection for carcinoma of the breast. Cochrane Database Syst Rev. 2013 Oct 20;2013(10):CD006823. doi: 10.1002/14651858.CD006823.pub2.

  PMID: 24158902 BACKGROUND

• Petrek JA, Blackwood MM. Axillary dissection: current practice and technique. Curr Probl Surg. 1995 Apr;32(4):257-323. doi: 10.1016/s0011-3840(05)80015-2. No abstract available.

  PMID: 7705102 BACKGROUND

• Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Pathophysiology of seroma in breast cancer. Breast Cancer. 2005;12(4):288-93. doi: 10.2325/jbcs.12.288.

  PMID: 16286909 BACKGROUND

• Bonnema J, Ligtenstein DA, Wiggers T, van Geel AN. The composition of serous fluid after axillary dissection. Eur J Surg. 1999 Jan;165(1):9-13. doi: 10.1080/110241599750007441.

  PMID: 10069628 BACKGROUND

• McCaul JA, Aslaam A, Spooner RJ, Louden I, Cavanagh T, Purushotham AD. Aetiology of seroma formation in patients undergoing surgery for breast cancer. Breast. 2000 Jun;9(3):144-8. doi: 10.1054/brst.1999.0126.

  PMID: 14731838 BACKGROUND

• Lotze MT, Duncan MA, Gerber LH, Woltering EA, Rosenberg SA. Early versus delayed shoulder motion following axillary dissection: a randomized prospective study. Ann Surg. 1981 Mar;193(3):288-95. doi: 10.1097/00000658-198103000-00007.

  PMID: 7011221 BACKGROUND

• Pinero-Madrona A, Castellanos-Escrig G, Abrisqueta-Carrion J, Canteras-Jordana M. Prospective randomized controlled study to assess the value of a hemostatic and sealing agent for preventing seroma after axillary lymphadenectomy. J Surg Oncol. 2016 Sep;114(4):423-7. doi: 10.1002/jso.24344. Epub 2016 Jun 23.

  PMID: 27338717 BACKGROUND

• Conversano A, Mazouni C, Thomin A, Gaudin A, Fournier M, Rimareix F, Bonastre J. Use of Low-Thrombin Fibrin Sealant Glue After Axillary Lymphadenectomy for Breast Cancer to Reduce Hospital Length and Seroma. Clin Breast Cancer. 2017 Jul;17(4):293-297. doi: 10.1016/j.clbc.2016.12.013. Epub 2017 Jan 10.

  PMID: 28161131 BACKGROUND

• Vasileiadou K, Kosmidis C, Anthimidis G, Miliaras S, Kostopoulos I, Fahantidis E. Cyanoacrylate Adhesive Reduces Seroma Production After Modified Radical Mastectomy or Quadrantectomy With Lymph Node Dissection-A Prospective Randomized Clinical Trial. Clin Breast Cancer. 2017 Dec;17(8):595-600. doi: 10.1016/j.clbc.2017.04.004. Epub 2017 Apr 13.

  PMID: 28673765 BACKGROUND

• Buch-Villa E, Castaner-Puga C, Delgado-Garcia S, Fuster-Diana C, Vidal-Herrador B, Ripoll-Orts F, Galeote-Quecedo T, Prat A, Andres-Matias M, Jimeno-Fraile J, Munoz-Sorsona E, Vento G, Gumbau-Puchol V, Adrianzen M, Lopez-Flor V, Ortega J. Clinical and cost outcomes of a polyethylene glycol (PEG)-coated patch versus drainage after axillary lymph node dissection in breast cancer: results from a multicentre randomized clinical trial. Br J Surg. 2023 Aug 11;110(9):1180-1188. doi: 10.1093/bjs/znad150.

  PMID: 37311694 DERIVED

Related Links

• Survey of Eortc QLQ- BR23
• Pathophysiology of seroma in breast cancer. Breast Cancer \[Internet\]. 2005;12(4):288-93.

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective multicentric randomized controlled clinical trial

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 27, 2020
• Study Start: March 1, 2020
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)