Clinical trial NCT05975359: Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
Official title: A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mastectomy
Implant Based Breast Reconstruction
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: IC Surgical
First posted: 2023-08-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
2. Indication for bilateral mastectomy
3. Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
4. Age 18 - 65
5. Female Sex
6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).

Exclusion Criteria:

1. Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
2. Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints.
3. Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and/ or other anticoagulation therapy in the past 60 days.
4. Are a smoker or use illicit drugs.
5. Any prior allergic reaction to Teflon.
6. Are pregnant or nursing.
7. Are undergoing a delayed reconstruction following mastectomy.
8. HIV infection, active UTI infection, or other active infection.
9. Those requiring more than one Manifold for fluid removal per breast will be excluded.

Primary outcomes:
measure: Device safety
timeFrame: Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.
measure: Time to drain removal
timeFrame: Drain removal typically occurs between 1-3 weeks post-op.
Secondary outcomes:
measure: Number of drain sites
timeFrame: This will be recorded by the surgeon immediately after completion of the stage 1 operation.
measure: Total fluid drained
timeFrame: Drain removal typically occurs between 1-3 weeks post-op.
measure: Time to initiate tissue expansion
timeFrame: Tissue expansion typically begins 3-6 weeks after stage 1 surgery.
measure: Patient satisfaction (BreastQ)
timeFrame: Administration of BreastQ will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).
measure: Patient satisfaction (study-specific survey)
timeFrame: Administration of the study specific survey will occur at specific post-operative time points (e.g. 1 week, 2 weeks, and at drain removal).
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
References: