Actively Recruiting
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
Led by Stanford University · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
I
IC Surgical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 to 65 years
- Female sex
- Ability to understand and willing to sign the IRB-approved informed consent in English
You will not qualify if you...
- Prior radiation to the breast or planned radiotherapy within the first year after surgery
- Enrollment in another study with investigational products that may interfere with endpoints
- Received oncologic chemotherapy within past 21 days or planned during study intervention
- Received antiplatelet (other than aspirin) or anticoagulation therapy in past 60 days
- Current smoker or illicit drug use
- Prior allergic reaction to Teflon
- Pregnant or nursing
- Undergoing delayed reconstruction following mastectomy
- HIV infection, active urinary tract infection, or other active infections
- Requirement of more than one Manifold per breast for fluid removal
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford Hospital and Clinics
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
K
Kassandra Carrion
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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