Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

Study Overview
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Brief Summary
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Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. 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, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.

Detailed Description
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Patients seeking a mastectomy with immediate tissue expander/implant-based breast reconstruction will be considered. Potential participants will be screened for inclusion and exclusion criteria and informed of the study protocols, risk, and potential benefits. Consenting patients who meet eligibility criteria will undergo bilateral mastectomy and immediate, implant-based breast reconstruction using a tissue expander. On the day of surgery, patient breasts will be randomized into the Interi cohort or the JP cohort, such that in each patient one breast receives the Interi drain and the other receives JP drains. Randomization will be stratified by the laterality of the primary tumor. The respective drains will be placed intraoperatively. Postoperative care 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 drain systems, which typically occurs 1-3 weeks after surgery. While drains are in place, patients will be required to monitor drain output and keep a daily drain log. Thereafter, follow-ups will be scheduled as needed (monthly) according to the usual clinical practice of implant-based breast reconstruction. This will include routine tissue expansion in preparation for the second stage expander to definitive implant exchange.

Official Title
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A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction

Conditions
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Mastectomy, Implant Based Breast Reconstruction

Intervention / Treatment
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* Device: Interi Manifold Drain System
* Device: Jackson Pratt Drain System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients ages 18 - 65 with a breast cancer diagnosis or other indication for bilateral mastectomy, who plan to undergo immediate implant-based pre-pectoral breast reconstruction, and who are willing and able to understand the informed consent document may be included. Exclusion Criteria: Patients with a history of radiation to the breast or who have planned radiotherapy to the breast within the first year post-operatively; have ECOG status > 2; are enrolled in another study that requires the concomitant use of any investigational product during the study period; have received chemotherapy within the past 21 days or have chemotherapy planned within the time fame of the study intervention (while drains are in place); have received anti-platelet therapy (other than aspirin) and/ or other anticoagulation therapy in the past 60 days; are a smoker or use illicit drugs; have a prior history of allergic reaction to teflon; are pregnant or nursing; plan to undergo a delayed reconstruction after mastectomy; have an HIV infection, active UTI or other infection; or those requiring more than one Interi manifold for fluid removal per breast will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients undergoing bilateral mastectomy will be eligible for this study. Each patient will receive both the Interi manifold (intervention arm) and the JP drain (comparison arm) placed in different breasts. Drain placement will be simultaneous. The laterality of different drain systems (intervention and comparison study arms) will be randomly assigned for each patient.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interi Manifold Drain System<br>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. | Device: Interi Manifold Drain System<br>* The Interi manifold surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the interi drain will be monitored daily and the Interi drain will remain in the surgical site until criteria for drain removal are met. Removal of the Interi drain will be performed in clinic by surgical staff.<br>* Other names: Interi manifold; Interi drain; Interi surgical drain;|
| Active Comparator: Jackson Pratt Drain System<br>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. | Device: Jackson Pratt Drain System<br>* The Jackson Pratt surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the Jackson Pratt drain will be monitored daily and the drain will remain in the surgical site until criteria for drain removal are met. Removal of the Jackson Pratt drain will be performed in clinic by surgical staff.<br>* Other names: JP drain; JP surgical drain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device safety | Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems. | Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months. | 
| Time to drain removal | The number of days between placement of each drain system (stage 1 surgery) and removal of the drain (defined as 2 consecutive days with drain output below 30 mL). | Drain removal typically occurs between 1-3 weeks post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of drain sites | The number of drain sites (holes exiting the surgical site) in each breast. | This will be recorded by the surgeon immediately after completion of the stage 1 operation. | 
| Total fluid drained | The amount of fluid (mL) collected by each surgical drain from the operative breast for the duration of drain placement will be recorded for both drain systems. | Drain removal typically occurs between 1-3 weeks post-op. | 
| Time to initiate tissue expansion | The amount of time in days after tissue expander placement (same operative time point as drain placement) for a patient to begin tissue expansion (when determined clinically appropriate by the attending physician). | Tissue expansion typically begins 3-6 weeks after stage 1 surgery. | 
| Patient satisfaction (BreastQ) | Both quality of life and patient satisfaction will be assessed by validated patient survey (BreastQ). Each breast will be assessed independently by the patient to determine if the type of drain has affected the patient's perception of their recovery. | Administration of BreastQ will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year). | 
| Patient satisfaction (study-specific survey) | Patient satisfaction with each drain system and ease of use will be assessed using a study-specific survey. | Administration of the study specific survey will occur at specific post-operative time points (e.g. 1 week, 2 weeks, and at drain removal). |