Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorStanford University

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Interi Manifold Drain System
  • Jackson Pratt Drain System

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

IC Surgical, Inc.

Collaborator