NCT05975359 Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
| NCT ID | NCT05975359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Mastectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-05 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-10-05 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. The purpose of this study is to compare the Interi system to standard JP drains across outcomes including number of surgical drain sites, complication rates, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.
Eligibility Criteria
Inclusion Criteria: 1. Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass. 2. Indication for bilateral mastectomy 3. Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix 4. Age 18 - 65 5. Female Sex 6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language). Exclusion Criteria: 1. Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively. 2. Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints. 3. Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and/ or other anticoagulation therapy in the past 60 days. 4. Are a smoker or use illicit drugs. 5. Any prior allergic reaction to Teflon. 6. Are pregnant or nursing. 7. Are undergoing a delayed reconstruction following mastectomy. 8. HIV infection, active UTI infection, or other active infection. 9. Those requiring more than one Manifold for fluid removal per breast will be excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05975359 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Mastectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05975359 currently recruiting?
Yes, NCT05975359 is actively recruiting participants. Contact the research team at kcarrion@stanford.edu for enrollment information.
Where is the NCT05975359 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT05975359 clinical trial?
NCT05975359 is sponsored by Stanford University. The trial plans to enroll 20 participants.