Interi Manifold vs. Jackson Pratt Drainage for Breast Reconstruction

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drain system called Interi Drain for patients having breast reconstruction after mastectomy. The new drain aims to remove fluids more effectively than the standard JP drains, helping patients heal faster and better. The Interi System is an internal, negative-pressure delivery system designed to remove excess fluid from internal tissue planes during breast reconstruction.

Eligibility Criteria

This trial is for women aged 18-65 who are planning immediate implant-based breast reconstruction after a mastectomy due to breast cancer or other reasons. They must understand the consent form and not be on certain blood thinners, smoke, use illicit drugs, have had recent radiation or chemotherapy, or plan delayed reconstruction.

Inclusion Criteria

I am a woman aged 18-65 planning to have breast reconstruction with implants after mastectomy.

Exclusion Criteria

Patients requiring more than one Interi manifold for fluid removal per breast

Patients who are smokers or use illicit drugs

I plan to have breast reconstruction surgery after my initial breast removal surgery.

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Treatment Details

Interventions

Interi Manifold Drain System (Procedure)
Jackson Pratt Drain System (Procedure)

Trial OverviewThe study compares two types of surgical drains used after breast reconstruction surgery: the new Interi Manifold Drain System and the traditional Jackson Pratt Drain System. It will look at how many drains are needed, complications, when drains can be removed, fluid volume drained, and patient satisfaction.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Interi Manifold Drain SystemExperimental Treatment1 Intervention

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.

Group II: Jackson Pratt Drain SystemActive Control1 Intervention

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.