Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 5, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
MastectomyImplant Based Breast Reconstruction
Interventions
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.

Trial Locations (1)

94304

RECRUITING

Stanford Hospital and Clinics, Palo Alto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

IC Surgical

UNKNOWN

lead

Stanford University

OTHER

NCT05975359 - Assessment of the Interi Manifold in Implant-Based Breast Reconstruction | Biotech Hunter | Biotech Hunter