Study of Interi Manifold Drain System for Breast Reconstruction
This study is looking at a new surgical drain system, the Interi Manifold Drain System, for patients undergoing implant-based breast reconstruction after a mastectomy. Surgical drains help prevent fluid buildup after surgery. The Interi system is designed to work better than the commonly used Jackson-Pratt (JP) drain by providing more consistent suction. Researchers want to see if the Interi system is safe and if it can reduce the time drains need to stay in place. You may be able to join if you are a woman between 18 and 65 years old, have a breast cancer diagnosis or genetic mutation with a breast mass, and are planning for a bilateral mastectomy with immediate implant-based breast reconstruction. The study aims to enroll 20 participants.
- Study design
- This is an interventional study where each participant will have one breast receive the Interi drain and the other receive the Jackson-Pratt drain. The study will enroll 20 participants.
- What's involved
- You will have drains placed during surgery and monitor their output daily. You will have weekly follow-up appointments until the drains are removed (typically 1-3 weeks post-op).
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have follow-up appointments as needed (monthly) until your second stage surgery, which typically occurs after 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Device safetyComplications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.
Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems.
- Time to drain removalDrain removal typically occurs between 1-3 weeks post-op.
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).