Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-29 @ 10:32 PM
Study NCT ID:
NCT06043557
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-24
First Post:
2023-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Reflection on Drain Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient preference of surgical drain placement', 'timeFrame': '1 week post surgery', 'description': 'Patients will complete a survey about their experience with the pertinent securement method/drain site - questions are essay style without a score or range\n\nIn the survey we created the level of negative factors (pulling, tugging, pain) as well as positive (ease of drain care, ease of personal hygiene) will be on a 1-100 scale. Therefore each side will get a conglomerate score of the following:\n\nTotal score = positive scores (average) - negative scores (average)\n\nThis result will be tabulated for each patient and used as a group analysis for preference. (Average scores for each side from all patients compared to one another.)'}], 'secondaryOutcomes': [{'measure': 'Number of days until drain removed', 'timeFrame': 'day of surgery up to 10 days', 'description': 'tracking number of days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominoplasty', 'plastic surgery', 'panniculectomy'], 'conditions': ['Abdominoplasty', 'Panniculectomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the ideal drain placement in patients undergoing abdominoplasty or panniculectomy. There are currently no patient reported outcome measurements on ideal drain placement and this study aims to collect objective and patient reported measures to standardize ideal drain placement.\n\nIn this study a medially and laterally placed drain will be compared to each other in each study participant. In this study subject will have two drains. One will be lateral and one medial. The drains will be secured and dressed in the same manner. At subjects planned post-operative visits, subjects will be asked to complete surveys to evaluate their experience with the drains. This study will not require additional clinic visits for study purposes.', 'detailedDescription': 'The primary goal of this proposal is to assess patient perspectives and satisfaction with the location of their drains after abdominoplasty and/or panniculectomy. This will be conducted as a prospective observational trial, where patients with scheduled abdominoplasty and/or panniculectomy will be invited to participate. Patients will be randomized to either A) left side lateral and right side medial or B) right side lateral with left side medial. Randomization will occur before study initiation with group A or group B being assigned to a study enrollment number.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 or older\n* patient of Department of Plastic and Reconstructive Surgery\n* able to sign English language Consent form\n* undergoing either abdominoplasty and/or panniculectomy.\n\nExclusion Criteria:\n\n* Patients with unilateral drain placement, unable to sign English language consent form\n* Patient under the age of 18.'}, 'identificationModule': {'nctId': 'NCT06043557', 'briefTitle': 'Patient Satisfaction and Reflection on Drain Placement', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy', 'orgStudyIdInfo': {'id': 'IRB00100958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'left side lateral and right side medial', 'description': 'left side lateral and right side medial', 'interventionNames': ['Procedure: Drain Placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'right side lateral with left side medial', 'description': 'right side lateral with left side medial', 'interventionNames': ['Procedure: Drain Placement']}], 'interventions': [{'name': 'Drain Placement', 'type': 'PROCEDURE', 'description': 'Surgical placement of drain based on subject randomization.', 'armGroupLabels': ['left side lateral and right side medial', 'right side lateral with left side medial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Adam Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}