Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-09 @ 6:13 PM
Study NCT ID:
NCT02263651
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2014-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004322', 'term': 'Drainage'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2014-09-29', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound seroma requiring aspiration or surgical intervention', 'timeFrame': 'Within 21 days following mastectomy', 'description': 'A seroma is defined as a postoperative fluid collection via palpation on clinical examination. The Common Terminology Criteria for Adverse Events (CTCAE) which is a descriptive terminology that can be used for adverse event reporting provide a grading scale for seromas (lymphoceles).\n\nOnly grade 2 and 3 seromas i.e. seromas requiring one or more aspirations or a surgical intervention will be considered as primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Wound seroma requiring aspiration or surgical intervention', 'timeFrame': 'Within 9 months following mastectomy'}, {'measure': 'Wound seroma whatever their type (requiring or not intervention)', 'timeFrame': 'Within 21 days following mastectomy'}, {'measure': 'Wound seroma whatever their type (requiring or not intervention)', 'timeFrame': 'Within 9 months following mastectomy'}, {'measure': 'Other wound complications', 'timeFrame': 'Within 21 days following mastectomy'}, {'measure': 'Other wound complications', 'timeFrame': 'Within 9 months following mastectomy'}, {'measure': 'Surgical morbidity', 'timeFrame': 'During surgical intervention'}, {'measure': 'Pain', 'timeFrame': 'Before surgery, day 1, 21 days and 9 months following mastectomy', 'description': 'Visual Analogue Scale'}, {'measure': 'Homolateral shoulder movement', 'timeFrame': 'Before surgery, 21 days and 9 months following mastectomy', 'description': 'The range of arm movement scored from 1 to 4 according to estimated angles of arm abduction as 1 (less than 90°), 2 (90-134°), 3 (135-179°) and 4 (180°)'}, {'measure': 'Cosmesis results', 'timeFrame': '21 days, 9 months following mastectomy', 'description': 'Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent'}, {'measure': 'Health related quality of life : EQ-5D-5L', 'timeFrame': 'Before surgery, day 1, 21 days and 9 months following mastectomy', 'description': 'The descriptive system comprises 5 dimensions : mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems'}, {'measure': 'Cost-effectiveness assessment', 'timeFrame': 'During the whole follow-up period i.e. 9 months following mastectomy', 'description': 'Incremental net monetary benefice'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Mastectomy', 'Seroma', 'Quilting suture'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '27044574', 'type': 'DERIVED', 'citation': 'Ouldamer L, Bonastre J, Brunet-Houdard S, Body G, Giraudeau B, Caille A. Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Apr 4;6(4):e009903. doi: 10.1136/bmjopen-2015-009903.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare quilting suture of the "dead space" without drainage of the pectoral area to conventional closure with drainage to prevent post-operative seroma requiring intervention (aspiration or surgical intervention) within 21 days after mastectomy for breast cancer.', 'detailedDescription': 'Eligible patients are patients with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection\n\nRandomization will be stratified by center and by type of surgery (mastectomy alone/ mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection).\n\nTwo follow-up visits will be performed: at 21 days and 9 months after surgery, these appointments are conventional, thus our trial will not modify usual follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women ≥ 18 years and ≤ 85 years\n* Women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection\n* Women that give her informed written consent\n* French social security affiliation\n\nExclusion Criteria:\n\n* Any physical or psychiatric condition that could impair with patient's ability to cooperate with postoperative data collection.\n* Women with indication of bilateral mastectomy or immediate reconstruction.\n* Degenerative neuromuscular disease with thoracic muscular damage\n* Planned ambulatory surgery"}, 'identificationModule': {'nctId': 'NCT02263651', 'acronym': 'QUISERMAS', 'briefTitle': 'Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage in Prevention of Seroma Formation After Mastectomy for Breast Cancer : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PHRCK13 - LO / QUISERMAS'}, 'secondaryIdInfos': [{'id': '2014-A00901-46', 'type': 'OTHER', 'domain': 'ID RCB'}, {'id': '140730B-12', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Closure with conventional technique with drainage', 'description': 'The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.', 'interventionNames': ['Procedure: Conventional closure with drainage']}, {'type': 'EXPERIMENTAL', 'label': 'Quilting suture without drainage', 'description': 'In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (\\<2cm) are placed from the skin flaps to the underlying muscle.', 'interventionNames': ['Procedure: Quilting suture without drainage']}], 'interventions': [{'name': 'Quilting suture without drainage', 'type': 'PROCEDURE', 'otherNames': ['Quilting suture'], 'description': 'In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (\\<2cm) are placed from the skin flaps to the underlying muscle. Minor dimpling is considered acceptable and is expected to resolve. If severe dimpling is observed, stitches are removed and replaced.\n\nEfficiency of quilting suture relies on a rigorous repartition of the sutures with a special attention taken to the obliteration of the largest potential dead spaces and the empty axillary apex.\n\nThe skin edges are sutured as stated before for the control group. Closed suction will not be used for draining the pectoral area.', 'armGroupLabels': ['Quilting suture without drainage']}, {'name': 'Conventional closure with drainage', 'type': 'PROCEDURE', 'otherNames': ['Conventional closure'], 'description': 'The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.\n\nThe skin is closed in two layers with absorbable sutures, a deep layer of 2.0 or 3.0 vicryl sutures or equivalent, and a subcuticular closure with absorbable 3.0 or 4.0 Monocryl sutures or equivalent.', 'armGroupLabels': ['Closure with conventional technique with drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Conception Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut POALI-CALMETTES', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Saint-Cyr-sur-Loire', 'country': 'France', 'facility': 'Alliance Clinic', 'geoPoint': {'lat': 47.4, 'lon': 0.66667}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHRU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Lobna OULDAMER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Tours'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}