Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT05975359

Conditions

Mastectomy

Implant Based Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Interi Manifold Drain System

Jackson Pratt Drain System

Study Details

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

Mastectomy

Implant Based Breast Reconstruction

Study ID

NCT05975359

Start date

Oct 5, 2023

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
2. Indication for bilateral mastectomy
3. Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
4. Age 18 - 65
5. Female Sex
6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).

Exclusion Criteria:

1. Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
2. 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.
3. 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.
4. Are a smoker or use illicit drugs.
5. Any prior allergic reaction to Teflon.
6. Are pregnant or nursing.
7. Are undergoing a delayed reconstruction following mastectomy.
8. HIV infection, active UTI infection, or other active infection.
9. Those requiring more than one Manifold for fluid removal per breast will be excluded.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Interi Manifold Drain System

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

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.

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. ]
  • Time to drain removal [ Time Frame: Drain removal typically occurs between 1-3 weeks post-op. ]

Central Contacts and Locations

Central contacts

Kassandra Carrion

(949) 521-0474kcarrion@stanford.edu

Locations

Stanford Hospital and Clinics

Recruiting

Palo Alto, California, United States, 94304

Contacts

Dung H Nguyen, MD, PharmD

650-725-2766nguyendh@stanford.edu

Kassandra Carrion

(949) 521-0474kcarrion@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-13.