Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05975359
Status
Recruiting
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Conditions

  • Implant Based Breast Reconstruction
  • Mastectomy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Interi Manifold Drain System — DEVICE
    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.
  • Jackson Pratt Drain System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 5, 2023
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Interi Manifold Drain System
    Following bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Interi manifold (intervention arm) will have the Interi manifold placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Interi drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log.
  • Active Comparator: Jackson Pratt Drain System
    Following bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Jackson Pratt drain (active comparator arm) will have the Jackson Pratt drain placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Jackson Pratt drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log.

Primary Outcome Measure

Device safety [ Time Frame: Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Hospital and ClinicsPalo AltoCalifornia94304
Dung H Nguyen, MD, PharmD
[email protected]
650-725-2766
Kassandra Carrion
[email protected]
(949) 521-0474

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By research site
Stanford Hospital and Clinics· Palo Alto, CA

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