Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

NCT05975359 | Recruiting DMC FDA Device

• 2 other identifiers: IRB-69609NCI-2024-02053
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Implant Based Breast Reconstruction; Mastectomy

Outcome Measures

Primary Outcomes (2)

• Device safety

  Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems.

  Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.

• Time to drain removal

  The number of days between placement of each drain system (stage 1 surgery) and removal of the drain (defined as 2 consecutive days with drain output below 30 mL).

  Drain removal typically occurs between 1-3 weeks post-op.

Secondary Outcomes (5)

• Number of drain sites

  This will be recorded by the surgeon immediately after completion of the stage 1 operation.

• Total fluid drained

  Drain removal typically occurs between 1-3 weeks post-op.

• Time to initiate tissue expansion

  Tissue expansion typically begins 3-6 weeks after stage 1 surgery.

• Patient satisfaction (BreastQ)

  Administration of BreastQ will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).

• Patient satisfaction (study-specific survey)

  Administration of the study specific survey will occur at specific post-operative time points (e.g. 1 week, 2 weeks, and at drain removal).

Study Arms (2)

Interi Manifold Drain System

EXPERIMENTAL

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.

Device: Interi Manifold Drain System

Jackson Pratt Drain System

ACTIVE COMPARATOR

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.

Device: Jackson Pratt Drain System

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.

Also known as: Interi manifold; Interi drain; Interi surgical drain

Interi Manifold Drain System

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.

Also known as: JP drain; JP surgical drain

Jackson Pratt Drain System

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• IC Surgical, Inc.: collaborator

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94304, United States

RECRUITING

Central Study Contacts

Kassandra Carrion

CONTACT

(949) 521-0474; kcarrion@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients undergoing bilateral mastectomy will be eligible for this study. Each patient will receive both the Interi manifold (intervention arm) and the JP drain (comparison arm) placed in different breasts. Drain placement will be simultaneous. The laterality of different drain systems (intervention and comparison study arms) will be randomly assigned for each patient.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 3, 2023
• Study Start: October 5, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)