NCT05975359

Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients seeking a mastectomy with immediate tissue expander/implant-based breast reconstruction will be considered. Potential participants will be screened for inclusion and exclusion criteria and informed of the study protocols, risk, and potential benefits. Consenting patients who meet eligibility criteria will undergo bilateral mastectomy and immediate, implant-based breast reconstruction using a tissue expander. On the day of surgery, patient breasts will be randomized into the Interi cohort or the JP cohort, such that in each patient one breast receives the Interi drain and the other receives JP drains. Randomization will be stratified by the laterality of the primary tumor. The respective drains will be placed intraoperatively. Postoperative care 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 drain systems, which typically occurs 1-3 weeks after surgery. While drains are in place, patients will be required to monitor drain output and keep a daily drain log. Thereafter, follow-ups will be scheduled as needed (monthly) according to the usual clinical practice of implant-based breast reconstruction. This will include routine tissue expansion in preparation for the second stage expander to definitive implant exchange.

Conditions

• Mastectomy
• Implant Based Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2023-10-05
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-08-03
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study