Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-27 @ 6:46 PM
Study NCT ID:
NCT04249934
Status:
WITHDRAWN
Last Update Posted:
2021-03-11
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Caffeine on Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patient and observer will be blinded to which group they were assigned.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to restrictions related to patient care secondary to covid pandemic.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of feasibility', 'timeFrame': 'approximately 6 months after recruitment starts', 'description': 'The total number of patients recruited per month, the rate of successful enrollment, and the rate of successful study completion will be evaluated.'}, {'measure': 'Absolute value of tissue oxygenation saturation (StO2)', 'timeFrame': 'up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)', 'description': 'St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.'}, {'measure': 'Absolute value of tissue oxygenation saturation (StO2) rate of change', 'timeFrame': 'up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)', 'description': 'St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.'}, {'measure': 'Absolute value of tissue oxygenation saturation (StO2) amount of change', 'timeFrame': 'up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)', 'description': 'St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.'}], 'secondaryOutcomes': [{'measure': 'Incidence of minor flap complications in the caffeine and non-caffeine groups', 'timeFrame': 'up to 30 days post-operatively', 'description': 'The complications will include delayed wound healing, wound dehiscence, hematoma, seroma formation, and infections requiring antibiotics.'}, {'measure': 'Incidence of major flap complications in the caffeine and non-caffeine groups', 'timeFrame': 'up to 30 days post-operatively', 'description': 'These complications will include any event that results in an unplanned trip to the operating room (e.g. arterial or venous thrombosis), and flap loss (e.g. flap failure, flap death).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Reconstruction', 'Deep Inferior Epigastric Perforator', 'Microvascular Free Flap Transfer']}, 'descriptionModule': {'briefSummary': 'Women that require breast reconstruction and meet eligibility will be enrolled in this study. The study is being completed to determine the effect of caffeine in deep inferior epigastric perforator (DIEP) flap perfusion using the Vioptix tissue oximeter monitor and to determine if caffeine in the acute postoperative period affects overall flap complication or loss (complete loss from anastomotic issue).\n\nThe researchers hypothesize that a single 8 ounce cup of regular coffee will not affect free flap perfusion as indicated by the Vioptix, and that it will not affect overall free flap survival at thirty days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'only women scheduled to undergo unilateral or bilateral microsurgical breast reconstruction will be enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System\n\nExclusion Criteria:\n\n* smokers\n* hepatic or renal disease (comorbidities that affect caffeine metabolism)\n* male'}, 'identificationModule': {'nctId': 'NCT04249934', 'briefTitle': 'The Effects of Caffeine on Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study', 'orgStudyIdInfo': {'id': 'HUM00142366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeinated Coffee', 'interventionNames': ['Dietary Supplement: Caffeinated Coffee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Decaffeinated Coffee', 'interventionNames': ['Dietary Supplement: DecaffeinatedCoffee']}], 'interventions': [{'name': 'Caffeinated Coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A single 8 ounce cup of regular starbucks coffee will be given to the participant in the am post operative day two. Participants will have 15 minutes to consume the coffee. Additionally, medical record data will be collected up to 30 days after surgery.', 'armGroupLabels': ['Caffeinated Coffee']}, {'name': 'DecaffeinatedCoffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A single 8 ounce cup of decaffeinated starbucks coffee will be given to the participant in the am post operative day two. Participants will have 15 minutes to consume the coffee. Additionally, medical record data will be collected up to 30 days after surgery.', 'armGroupLabels': ['Decaffeinated Coffee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Adeyiza Momoh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Theodore A Kung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Adeyiza Momoh', 'investigatorAffiliation': 'University of Michigan'}}}}