Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction
Stanford University
20 participants
Oct 5, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
- Indication for bilateral mastectomy
- Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
- Age 18 - 65
- Female Sex
- Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).
Exclusion Criteria9
- Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
- 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.
- 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.
- Are a smoker or use illicit drugs.
- Any prior allergic reaction to Teflon.
- Are pregnant or nursing.
- Are undergoing a delayed reconstruction following mastectomy.
- HIV infection, active UTI infection, or other active infection.
- Those requiring more than one Manifold for fluid removal per breast will be excluded.
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Interventions
The Interi manifold surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the interi drain will be monitored daily and the Interi drain will remain in the surgical site until criteria for drain removal are met. Removal of the Interi drain will be performed in clinic by surgical staff.
The Jackson Pratt surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the Jackson Pratt drain will be monitored daily and the drain will remain in the surgical site until criteria for drain removal are met. Removal of the Jackson Pratt drain will be performed in clinic by surgical staff.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05975359