Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
Indication for bilateral mastectomy
Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
Age 18 - 65
Disqualifiers
Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
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.
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.
Are a smoker or use illicit drugs.
Trial design
Design model
Parallel
Treatments tested in this trial
Interi Manifold Drain System
DeviceThe 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.
Jackson Pratt Drain System
DeviceThe 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Interi Manifold Drain SystemExperimental treatment 1 intervention
Group B: Jackson Pratt Drain SystemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Device safety
Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems.
Time frame
Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.2
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).
Time frame
Drain removal typically occurs between 1-3 weeks post-op.Secondary outcomes
1
Number of drain sites
The number of drain sites (holes exiting the surgical site) in each breast.
Time frame
This will be recorded by the surgeon immediately after completion of the stage 1 operation.2
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.
Time frame
Drain removal typically occurs between 1-3 weeks post-op.3
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).
Time frame
Tissue expansion typically begins 3-6 weeks after stage 1 surgery.4
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.
Time frame
Administration of BreastQ will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
IC Surgical, Inc.
Collaborator
Source ClinicalTrials.gov