Assessment of the Interi Manifold in Implant-Based Breast Reconstruction (NCT05975359) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
United States20 participantsStarted 2023-10-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Device safety
Timeframe: Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.
2
Time to drain removal
Timeframe: Drain removal typically occurs between 1-3 weeks post-op.