← Back to Search

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

Study 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.

Find a Location

Who is running the clinical trial?

IC SurgicalUNKNOWN
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,330 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to volunteer for this clinical trial?

"To partake in this clinical trial, mastectomy patients that are 18-65 years old may submit an application. A maximum of 20 applicants will be selected and accepted into the study."

Answered by AI

Are there openings available to participate in this medical trial?

"The information available on clinicaltrials.gov shows that this trial is not actively seeking patients, despite its initial post date of August 1st 2023 and most recent update occurring July 27th 2023. However, there are 15 other trials that remain open to recruitment at the present time."

Answered by AI

What are the principal aims of this clinical experiment?

"This experiment's primary purpose is to track the time it takes for surgery patients to have their drains removed. Secondary objectives include monitoring total fluid drained, amount of time before tissue expansion begins, and patient satisfaction (as measured by BreastQ survey). Patients will be monitored until they receive permanent implants after 6 months."

Answered by AI

Is this experimentation open to elderly participants?

"Conforming to the selection criteria for this research, participants must be aged 18-65 at minimum."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
Dung Nguyen 2023. "Assessment of the Interi Manifold in Implant-Based Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05975359.
~7 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top