Interi Manifold vs. Jackson Pratt Drainage for Breast Reconstruction

Overseen By Kassandra Carrion

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Radiation, Chemotherapy, Smoking, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the new Interi Manifold Drain System compared to the standard Jackson Pratt (JP) drain for individuals undergoing breast reconstruction after a mastectomy. The researchers aim to determine if the Interi system, with its new suction method, can improve factors such as the number of surgery drain sites needed, the speed of drain removal, and overall patient satisfaction. It targets individuals diagnosed with breast cancer or a genetic breast mass who plan to have both breasts removed and immediate implant-based reconstruction. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance post-surgical recovery experiences.

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.

What prior data suggests that the Interi Manifold Drain System is safe for breast reconstruction?

Research has shown that the Interi Manifold Drain System is generally safe for patients. Studies have found that, compared to standard JP (Jackson-Pratt) drains, the Interi system results in fewer complications, such as fluid build-up and other issues, indicating it is well-tolerated by most patients.

In trials, patients using the Interi system experienced consistent suction and fewer fluid drainage problems. This suggests that the new system may aid in smoother recovery after surgery.

The Interi system is still undergoing further testing to confirm these findings, but early results are promising for its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Interi Manifold and Jackson Pratt Drain Systems because these approaches aim to improve recovery after breast reconstruction surgery. The Jackson Pratt Drain is a well-known system used to prevent fluid build-up post-surgery, requiring continuous monitoring until the fluid level decreases. The Interi Manifold Drain System, on the other hand, is being explored for its potential to offer similar drainage with possible enhancements in patient comfort or efficiency. Both systems are being closely monitored to determine their effectiveness in reducing recovery time and improving patient experiences.

What evidence suggests that the Interi Manifold Drain System is effective for breast reconstruction?

Research has shown that the Interi Manifold Drain System, one of the treatments studied in this trial, can aid in breast reconstruction surgery. One study found that the Interi system was removed much sooner than traditional drains, with an average removal time of 16.5 days compared to 19.6 days. It also had a lower rate of fluid buildup, known as seroma, occurring in only 4.1% of cases. The Interi system provides steady suction and better fluid control, reducing complications after surgery. These findings suggest that the Interi system could lead to better results compared to the standard Jackson Pratt drains, the other treatment option evaluated in this trial. ^{2 4 5 6 7}

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.

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?

Group I: Interi Manifold Drain System Experimental Treatment 1 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 System Active Control 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

IC Surgical, Inc.

Industry Sponsor

IC Surgical

Collaborator

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05975359

Assessment of the Interi Manifold in Implant-Based Breast ... 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, ...

2. icsurgical.com icsurgical.com/technology/data-and-evidence/

Clinical and Pre-clinical Studies Interi was removed significantly earlier than drains (16.5 vs 19.6 days; P=<0.0001) and was associated with a significantly lower incidence of seroma (4.1% ...

3. journals.lww.com journals.lww.com/prsgo/fulltext/2023/09000/reduction_in_seroma_and_other_complications_with_a.23.aspx

Reduction in Seroma and Other Complications with a Novel... Interi effectively reduced dead space and evacuated fluid from internal tissue planes, thereby decreasing seroma and other complications after prepectoral ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-02053

Interi Drain System Compared to Traditional Surgical ... This clinical trial evaluates the Interi drain system compared to traditional surgical drains to improve surgical outcomes in breast cancer patients.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05975359/assessment-of-the-interi-manifold-in-implant-based-breast-reconstruction

Assessment of the Interi Manifold in Implant-Based Breast ... 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, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10489512/

Reduction in Seroma and Other Complications with a ... The purpose of this study is to report on the safety and effectiveness of Interi, compared with standard drains, in a larger patient population ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35106264/

A Novel Internal Negative Pressure Delivery System in ... This retrospective study evaluated the safety and effectiveness of Interi compared with standard drains in consecutive patients undergoing ...