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Compensation: Varies

Number of Visits: 1

20 Participants Needed

Interi Manifold vs. Jackson Pratt Drainage for Breast Reconstruction

Overseen ByKassandra Carrion

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Radiation, Chemotherapy, Smoking, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have received chemotherapy in the past 21 days or antiplatelet/anticoagulation therapy (other than aspirin) in the past 60 days, you may not be eligible to participate.

Is the Interi Manifold and Jackson Pratt Drainage safe for use in humans?

The Interi System, used in breast reconstruction, has shown a reduction in complications like seroma compared to standard drains, indicating it is generally safe. The Jackson-Pratt (JP) system is widely used in surgeries and is considered safe, though there can be rare complications like retained drain parts.¹ ² ³ ⁴ ⁵

How does the Interi Manifold Drain System differ from the Jackson Pratt Drain System in breast reconstruction?

The Interi Manifold Drain System is unique because it uses an internal negative pressure system with a branching manifold to cover a broad area of internal tissue, which helps reduce complications like seroma more effectively than standard drains like the Jackson Pratt system.² ³ ⁴ ⁶ ⁷

What data supports the effectiveness of the Interi Manifold Drain System compared to the Jackson Pratt Drain System for breast reconstruction?

Research shows that the Interi Manifold Drain System significantly reduces seroma (fluid buildup) and other complications after breast reconstruction compared to standard drains, like the Jackson Pratt system, by using a unique internal negative pressure system to remove excess fluid more effectively.² ³ ⁶ ⁷ ⁸

Are You a Good Fit for This Trial?

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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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Bilateral mastectomy and immediate implant-based breast reconstruction with randomization to either Interi or JP drain system

1 day

1 visit (in-person)

Postoperative Follow-up

Weekly follow-ups with documentation of clinical data until drain removal, typically 1-3 weeks post-surgery

1-3 weeks

Weekly visits (in-person)

Tissue Expansion

Routine tissue expansion in preparation for the second stage expander to definitive implant exchange

3-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment until stage 2 surgery

6 months

What Are the Treatments Tested in This Trial?

Interventions

Interi Manifold Drain System
Jackson Pratt Drain System

Trial Overview The 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.

How Is the Trial Designed?

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.