Overview
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.
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
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.