Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT06725459
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2024-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NPWT Reduction Mammaplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536821', 'term': 'Gigantomastia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Prevena Restor Bella Form™ wound vacuum will be applied to the reduction mammaplasty incision as directed for up to 7 days postoperatively. Prevena Restor Bella Form™ is a ciNPWT management system. ciNPWT management systems apply negative pressure to the incision and structurally stabilize the surrounding tissues.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2024-11-15', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Postoperative Wound Complications', 'timeFrame': '30 days postoperatively', 'description': 'The primary outcome measure is the incidence of postoperative wound complications within 30 days following reduction mammaplasty. This includes surgical wound dehiscence, delayed wound healing, and surgical site infections (SSIs).'}], 'secondaryOutcomes': [{'measure': 'Patient-Reported Pain (VAS)', 'timeFrame': 'Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively', 'description': 'Patient-reported pain will be assessed using the Visual Analog Scale (VAS) with scores ranging from 0 (no pain) to 10 (maximal imaginable pain).'}, {'measure': 'Scar Quality (POSAS)', 'timeFrame': '1 month and 3 months postoperatively', 'description': 'Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) at 1 and 3 months postoperatively. The scale ranges from 6 (normal skin) to 60 (worst imaginable scar).'}, {'measure': 'Patient Satisfaction with Breasts (BREAST-Q)', 'timeFrame': 'Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively', 'description': 'Patient satisfaction with their breasts will be measured using the standardized BREAST-Q 2.0© questionnaire at the preoperative consultation, and at 1 week, 1 month, 3 months, and 6 months postoperatively.'}, {'measure': 'Cost Differential: Dressing-Related Costs', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Costs associated with dressings will include the unit price of ciNPWT and standard adhesive dressings and healthcare professional time for application and removal.'}, {'measure': 'Cost Differential: Healthcare Resource Use', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Healthcare resource use will include hospital stay durations, additional procedures for managing complications, and any unplanned follow-up visits.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['mammaplasty', 'macromastia', 'breast reduction', 'negative pressure therapy'], 'conditions': ['Healthy', 'Macromastia', 'Negative Pressure Therapy', 'Mammaplasty', 'Wound Healing']}, 'descriptionModule': {'briefSummary': 'In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure wound therapy versus standard adhesive dressing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients\n* Age 18 years or older\n* Scheduled to undergo bilateral reduction mammaplasty with a Wise pattern (anchor) incision and a superomedial, inferior, or central mound pedicle at MedStar Georgetown University Hospital or MedStar Good Samaritan Hospital\n* Able to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Biologically male patients\n* Scheduled to undergo unilateral breast mammaplasty\n* Currently pregnant or lactating\n* Use of steroids or other immune modulators known to affect wound healing\n* Current smokers who have not paused for a minimum of 4 weeks prior to surgery\n* History of breast cancer\n* History of oncologic or reconstructive breast surgery\n* History of radiation to the breast\n* History of chemotherapy or hormone therapy\n* Tattoos in the area of skin incision\n* Skin conditions known to affect wound healing or scarring of the breast (e.g., cutis laxa)\n* Significant history of scar problems (e.g., hypertrophic scarring or keloids) post-surgical incisions with active bleeding\n* Exposure of blood vessels, organs, bone, or tendon at the base of the reference wound\n* Known allergies to product components (e.g., medical or NPWT tape)\n* Unable to comply with NPWT requirements, including those unable to present for postoperative follow-up\n* Lactating at the time of surgery\n* Require deviation from standard operative or closure techniques (e.g., staples, free nipple grafts)\n* Considered part of a vulnerable population (adults unable to consent, infants, children, teenagers, pregnant women, prisoners)\n* Experience intraoperative complications due to surgical complications not related to the NPWT instrumentation (e.g., expanding hematoma)'}, 'identificationModule': {'nctId': 'NCT06725459', 'briefTitle': 'NPWT Reduction Mammaplasty', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty', 'orgStudyIdInfo': {'id': 'STUDY00007266'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prophylactic ciNPWT', 'description': 'Participants in this arm will receive the prophylactic closed incision negative pressure wound therapy (ciNPWT) on one breast following reduction mammaplasty. The ciNPWT will be applied for up to 7 days postoperatively to promote wound healing and prevent complications.', 'interventionNames': ['Device: Prophylactic ciNPWT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Adhesive Dressing', 'description': 'Participants in this arm will receive the standard adhesive strip dressing (Prineo Ethicon NJ) on the other breast following reduction mammaplasty. The standard dressing will be used as a control to compare postoperative outcomes against the ciNPWT.', 'interventionNames': ['Other: Standard Adhesive Dressing']}], 'interventions': [{'name': 'Prophylactic ciNPWT', 'type': 'DEVICE', 'description': 'The prophylactic closed incision negative pressure wound therapy (ciNPWT) will be applied to one breast for up to 7 days postoperatively to promote wound healing and prevent complications.', 'armGroupLabels': ['Prophylactic ciNPWT']}, {'name': 'Standard Adhesive Dressing', 'type': 'OTHER', 'description': 'The standard adhesive strip dressing will be applied to one breast immediately after surgery. It provides a protective covering for the wound during the initial healing phase and is the standard of care for incision management.', 'armGroupLabels': ['Standard Adhesive Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenneth L Fan, MD', 'role': 'CONTACT', 'email': 'kenneth.l.fan@medstar.net', 'phone': '202-444-8751'}, {'name': 'Ryan P Lin, MD', 'role': 'CONTACT', 'email': 'Ryan.Lin@medstar.net', 'phone': '2407787804', 'phoneExt': '1'}, {'name': 'Kenneth L Fan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medstar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Ryan P Lin, MD', 'role': 'CONTACT', 'email': 'Ryan.Lin@medstar.net', 'phone': '2407787804', 'phoneExt': '1'}, {'name': 'Kenneth L Fan, MD', 'role': 'CONTACT', 'email': 'kenneth.l.fan@medstar.net', 'phone': '(202) 444-8751', 'phoneExt': '1'}], 'overallOfficials': [{'name': 'Kenneth L Fan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MedStar Georgetown University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}