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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• Female Sex

• Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).

Locations
United States
California
Stanford Hospital and Clinics
RECRUITING
Palo Alto
Contact Information
Primary
Kassandra Carrion
kcarrion@stanford.edu
(949) 521-0474
Time Frame
Start Date: 2023-10-05
Estimated Completion Date: 2025-09
Participants
Target number of participants: 20
Treatments
Experimental: Interi Manifold Drain System
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.
Active_comparator: Jackson Pratt Drain System
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: IC Surgical

This content was sourced from clinicaltrials.gov

Similar Clinical Trials