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Procedure

Interi Manifold vs. Jackson Pratt Drainage for Breast Reconstruction

N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administration of breastq will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).
Awards & highlights

Summary

This trial is comparing a new drain system to the standard one used for breast cancer patients who have a reconstruction surgery. The new system is designed to be more effective and improve outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort at drain sites, risk of infection from prolonged drain use if suction is inconsistent with JP drains. The Interi system aims to reduce these issues but specific side effects aren't listed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administration of breastq will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).
This trial's timeline: 3 weeks for screening, Varies for treatment, and administration of breastq will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device safety
Time to drain removal
Secondary outcome measures
Number of drain sites
Patient satisfaction (BreastQ)
Patient satisfaction (study-specific survey)
+2 more

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Post-mastectomy treatments primarily aim to manage dead space, prevent seroma formation, and ensure effective drainage to promote healing. The Interi Drain system, which offers consistent suction and improved surgical site coverage, enhances these outcomes by providing a more reliable and efficient method of fluid removal compared to traditional Jackson-Pratt (JP) drains. This is crucial for mastectomy patients as it reduces the risk of complications, shortens recovery time, and improves overall patient satisfaction.
[Primary and adjuvant treatment of breast cancer: an update].A surgical subculture. The use of mastectomy to treat breast cancer.Surgical Dead End in a Renal Transplant Recipient Associated With a Rare Thrombohemorrhagic Syndrome.

Find a Location

Who is running the clinical trial?

IC SurgicalUNKNOWN
Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,919 Total Patients Enrolled
1 Trials studying Mastectomy
30 Patients Enrolled for Mastectomy

Media Library

Interi Manifold Drain System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05975359 — N/A
Mastectomy Research Study Groups: Jackson Pratt Drain System, Interi Manifold Drain System
Mastectomy Clinical Trial 2023: Interi Manifold Drain System Highlights & Side Effects. Trial Name: NCT05975359 — N/A
Interi Manifold Drain System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975359 — N/A
~0 spots leftby Aug 2024