Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
Study NCT ID:
NCT06811857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2025-01-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
This Study Aims to Explore the Efficacy of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-01', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The SKIN Area Score of Clavien-Dindo classification', 'timeFrame': 'At baseline, weekly during HBO treatment (up to 8 weeks), 2 weeks after the end of HBO treatment, 4 weeks after the end of HBO treatment'}], 'secondaryOutcomes': [{'measure': 'NAC necrosis Degree', 'timeFrame': 'At baseline, weekly during HBO treatment (up to 8 weeks), 2 weeks after the end of HBO treatment, 4 weeks after the end of HBO treatment'}, {'measure': 'Number of times for hyperbaric oxygen treatment', 'timeFrame': 'at the end of the study (at 3 month)'}, {'measure': 'Interval between surgery and hyperbaric oxygen treatment', 'timeFrame': 'baseline'}, {'measure': 'Breast-Q questionnaire', 'timeFrame': 'At baseline, end of hyperbaric oxygen treatment(at 6-8 weeks), 2 weeks after end of hyperbaric oxygen treatment, 4 weeks after end of hyperbaric oxygen treatment', 'description': 'The BREAST-Q is a rigorously developed patient-reported outcome measure (PROM) designed to evaluate outcomes among women undergoing different types of breast surgery from the patient perspective.'}, {'measure': 'side effects of hyperbaric oxygen treatment', 'timeFrame': 'During hyperbaric oxygen therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flap Necrosis', 'Flap Ischemia']}, 'descriptionModule': {'briefSummary': 'The expectation of our study was to explore the efficacy of using hyperbaric oxygen to rescue flap ischaemic necrosis after breast cancer surgery.', 'detailedDescription': 'Hyperbaric oxygen is commonly used to improve tissue oxygen saturation rescue flap ischemia, and treatment of diabetic foot ulcers. In the current study, there are also a number of case reports attempting to explore the role of hyperbaric oxygen in the treatment of postoperative skin flaps and nipple areola necrosis after breast surgery and significant efficacy has been obtained. Our study expects to use the treatment of hyperbaric oxygen to save patients with signs of flap ischemic necrosis after breast cancer surgery and to improve the quality of life and prognosis of patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. understand the study procedure, participate in the study voluntarily and sign the informed consent form\n2. aged ≥ 18 years and ≤ 60 years, female\n3. ECOG 0-2\n4. patients with The SKIN Score Degree of B-D and The SKIN area of 1-3 in the Clavien-Dindo classification after breast cancer surgery；\n\nExclusion Criteria:\n\n1. Contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (Eustachian tube dysfunction, recurrent episodes of vertigo), eye disease (retinal detachment).\n2. Pregnancy or lactation.\n3. any other condition that the investigators think the patient is unsuitable for participation in the study'}, 'identificationModule': {'nctId': 'NCT06811857', 'briefTitle': 'This Study Aims to Explore the Efficacy of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'An Exploration of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery', 'orgStudyIdInfo': {'id': 'KY2024-1048-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyperbaric oxygen group', 'description': 'The hyperbaric group is given a total of 30-40 sessions of hyperbaric oxygen therapy (100% oxygen at a pressure of 2.0 ATA) and povidone-iodine wet compresses.', 'interventionNames': ['Device: hyperbaric oxygen therapy and povidone-iodine wet compresses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal group', 'description': 'The control group is given wet compresses of povidone-iodine.', 'interventionNames': ['Other: wet compresses of povidone-iodine']}], 'interventions': [{'name': 'hyperbaric oxygen therapy and povidone-iodine wet compresses', 'type': 'DEVICE', 'description': 'The hyperbaric oxygen group receives 30-40 sessions of hyperbaric oxygen therapy (100% oxygen at a pressure of 2.0 ATA) and povidone-iodine wet compresses.', 'armGroupLabels': ['hyperbaric oxygen group']}, {'name': 'wet compresses of povidone-iodine', 'type': 'OTHER', 'description': 'wet compresses of povidone-iodine', 'armGroupLabels': ['Normal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Kun Wang, Phd', 'role': 'CONTACT', 'email': 'gzwangkun@126.com', 'phone': '13922118086'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Kun wang, PhD', 'role': 'CONTACT', 'email': 'gzwangkun@126.com', 'phone': '86+15989223200'}, {'name': 'Kun Wang', 'role': 'CONTACT', 'email': 'gzwangkun@126.com'}], 'overallOfficials': [{'name': 'Kun Wang Kun Wang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kun Wang', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}