Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-28 @ 1:58 PM
Study NCT ID:
NCT04487561
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D049291', 'term': 'Seroma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective multicentric randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To develop seroma after surgery', 'timeFrame': 'Percentage, through study completion, an average of 2 months', 'description': '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.'}, {'measure': 'total volumen of the seroma', 'timeFrame': 'from 24 hours until there is no seroma, assessed up to 2 months', 'description': '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,'}, {'measure': 'Seroma punctures', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'the total number of punctures needed'}, {'measure': 'complications', 'timeFrame': 'from 24 hours until there is no complications, assessed up to 2 months', 'description': 'Other complications collected throughout the study include: bruising (yes / no), pain (yes / no), problems with aspiration drainage (yes / no)'}], 'secondaryOutcomes': [{'measure': 'quality of life in patients', 'timeFrame': '1 week after surgery with Eortc QLQ-BR23', 'description': 'Compare the quality of life in patients after receiving either of these procedures using the Eortc QLQ-BR23 survey'}, {'measure': 'the costs', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Compare the costs of both procedures by quantifying the costs of materials and consult time used in both procedures'}, {'measure': 'body mass index', 'timeFrame': 'weight (kg) / height (m2). In the first consultation', 'description': 'body mass index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aspirative drainage', 'hemopatch', 'seroma', 'breast cancer'], 'conditions': ['Breast Cancer', 'Breast-conserving Surgery', 'Axillary Lymph Node Dissection']}, 'referencesModule': {'references': [{'pmid': '29658322', 'type': 'BACKGROUND', 'citation': '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': '19289285', 'type': 'BACKGROUND', 'citation': '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': '6359504', 'type': 'BACKGROUND', 'citation': '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': '23865902', 'type': 'BACKGROUND', 'citation': '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': '29948418', 'type': 'BACKGROUND', 'citation': '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': '20827578', 'type': 'BACKGROUND', 'citation': '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': '24158902', 'type': 'BACKGROUND', 'citation': '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': '7705102', 'type': 'BACKGROUND', 'citation': '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': '16286909', 'type': 'BACKGROUND', 'citation': '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': '10069628', 'type': 'BACKGROUND', 'citation': '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': '14731838', 'type': 'BACKGROUND', 'citation': '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': '7011221', 'type': 'BACKGROUND', 'citation': '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': '27338717', 'type': 'BACKGROUND', 'citation': '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': '28161131', 'type': 'BACKGROUND', 'citation': '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': '28673765', 'type': 'BACKGROUND', 'citation': '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': '37311694', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.eortc.org', 'label': 'Survey of Eortc QLQ- BR23'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/16286909', 'label': 'Pathophysiology of seroma in breast cancer. Breast Cancer \\[Internet\\]. 2005;12(4):288-93.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBased 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.\n\nHypothesis: 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.', 'detailedDescription': '1. Introduction:\n\n In the surgical management of breast cancer, a conservative approach is the "gold standard" for the mammary region. For the axillary region, however, this depends on the results of the sentinel lymph node biopsy (SLNB) with axillary lymph node dissection (ALND) continuing to be an indispensable procedure when the disease reaches this level.\n\n The complications that arise from this procedure can be divided in two groups: 1) early: seromas and nerve lesions and 2) late: lymphedema, functional disorders in shoulder movement and post-mastectomy pain syndrome.\n\n Seromas are the most frequent complications after an ALND. In themselves, they do not carry a high risk of morbidity. However, they delay healing of the surgical wound, increasing the risk of infection and number of ambulatory visits and furthermore, resulting in a deferral in the start of adjuvant therapies such as radio and chemotherapy.\n\n 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.\n\n Hemopatch® is a hemosthatic sealer made from reabsorbable collagen. It comes in the from of patch, with CE marking that is already being used in the clinical setting in Spain and the rest of Europe.\n\n Taking into account the factors that reduce seroma formation after ALND and the characteristics of the patch, its application after surgery could be useful in preventing seroma formation. More specifically, the patch has proven to act as a\n * Hemosthatic, improving the first phase of inflammation\n * Adhesive, reducing the dead space left after ALND\n * Sealer, decreasing the exudate\n2. Rationale Based on this premise and in the context of a clinical protocol after the introduction of the patch in daily clinical practice, it was used on 28 patients that underwent ALND, obtaining favourable clinical results. This is 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.\n3. Hypothesis Placing a Hemopatch ® instead of an aspirative drainage in women after undergoing ALND 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of breast cancer,\n* scheduled for surgical treatment including conservative surgery and ALND.\n* Signed informed consent for ALND.\n\nExclusion Criteria:\n\n* Selective sentinel node biopsy negative.\n* Subsidiary mastectomy patients.\n* Denial of informed consent for axillary lymphadenectomy.'}, 'identificationModule': {'nctId': 'NCT04487561', 'acronym': 'REDHEMOPACH', 'briefTitle': 'Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Investigación del Hospital Clínico de Valencia'}, 'officialTitle': 'Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy: Randomized, Controlled, Multicenter Clinical Study', 'orgStudyIdInfo': {'id': 'REDHEMOPACH'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'hemopatch', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['Hemopatch']}, {'name': 'Aspirative drainage', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['aspirative drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Investigación del Hospital Clínico de Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elvira Buch', 'investigatorAffiliation': 'Fundación para la Investigación del Hospital Clínico de Valencia'}}}}