What side effects are associated with this type of intervention?

Common treatments for mastectomy involving surgical drains, such as the Jackson-Pratt (JP) drain, often result in side effects like seroma formation, infection, pain, and prolonged drainage time. The novel Interi Drain system, designed to provide consistent suction and improved surgical site coverage, aims to mitigate these issues, potentially reducing the incidence of seromas and infections while enhancing patient comfort and satisfaction.

What prior FDA approvals exist?

The FDA has approved various surgical drains for use in post-mastectomy care to manage dead space and prevent seroma formation. One of the most commonly used drains is the Jackson-Pratt (JP) drain, which has been a standard in surgical procedures for many years. The Interi Drain system, which offers consistent suction and improved surgical site coverage, represents an advancement over traditional JP drains. While specific FDA approvals for the Interi Drain system are not detailed, its design aims to address the limitations of existing drains by providing more reliable suction and better coverage, potentially improving patient outcomes in post-mastectomy recovery.

What other types of research exist?

Promising alternatives to the Interi Drain system for mastectomy patients include advanced vacuum-assisted closure (VAC) systems and novel multi-branched drainage systems. These alternatives aim to provide consistent suction and better surgical site coverage, potentially reducing complications and improving patient outcomes.

← 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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

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).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Device safety

Time to drain removal

Secondary study objectives

Number of drain sites

Patient satisfaction (BreastQ)

Patient satisfaction (study-specific survey)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out

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.