Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-31 @ 5:12 AM
Study NCT ID:
NCT02627560
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D049291', 'term': 'Seroma'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-08', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bleeding as defined by drain production per hour the first 24 hours', 'timeFrame': '24 hours postoperatively', 'description': 'Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml'}], 'secondaryOutcomes': [{'measure': 'Daily drain production up to drain removal - cumulative volume', 'timeFrame': '3 weeks'}, {'measure': 'number of patients having surgical bleeding in need of re-operation', 'timeFrame': '3 weeks'}, {'measure': 'number of postoperative aspirations of clinical seroma', 'timeFrame': 'up to 3 months'}, {'measure': 'chronic seroma (lasting more than three months)', 'timeFrame': '3 months', 'description': 'volume of seroma aspirated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Administration, topical', 'Tranexamic acid', 'Postoperative care', 'Mastectomy'], 'conditions': ['Postoperative Hemorrhage', 'Breast Neoplasms', 'Seroma']}, 'referencesModule': {'references': [{'pmid': '26349843', 'type': 'BACKGROUND', 'citation': 'Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.'}, {'pmid': '32207575', 'type': 'RESULT', 'citation': 'Ausen K, Hagen AI, Ostbyhaug HS, Olafsson S, Kvalsund BJ, Spigset O, Pleym H. Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. BJS Open. 2020 Apr;4(2):216-224. doi: 10.1002/bjs5.50248. Epub 2019 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer.\n\nAfter surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer\n* undergoing unilateral mastectomy with or without axillary node dissection\n* received adequate oral and written information about the study and signed an informed-consent form\n\nExclusion Criteria:\n\n* pregnant or breastfeeding\n* known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure\n* known allergy to tranexamic acid/Cyklokapron®'}, 'identificationModule': {'nctId': 'NCT02627560', 'briefTitle': 'The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study', 'orgStudyIdInfo': {'id': '2015/1722'}, 'secondaryIdInfos': [{'id': '2015-003160-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'topical tranexamic acid', 'description': 'tranexamic acid to be smeared on surgical wounds before closure', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo control', 'description': 'saline to be smeared on surgical wounds before closure', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': 'moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml', 'armGroupLabels': ['topical tranexamic acid']}, {'name': 'saline', 'type': 'DRUG', 'description': 'moisten the surgical wound surface with 20 ml placebo (0.9% saline)', 'armGroupLabels': ['placebo control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ålesund', 'country': 'Norway', 'facility': 'Department of Surgery, Aalesund Hospital', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}, {'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Petter Aadahl, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olavs Hospital'}, {'name': 'Sverrir Olafsson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ålesund Sykehus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alesund Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}