Comparing two types of surgical drains for breast reconstruction after mastectomy
A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction
This study is testing whether a new type of surgical drain works better than the standard drain for patients getting breast reconstruction after a mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05975359 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Interi Drain system compared to the traditional Jackson-Pratt (JP) drain in patients undergoing implant-based breast reconstruction following mastectomy. Participants will be randomized to receive either drain type in each breast during surgery, allowing for direct comparison of outcomes such as complication rates, time to drain removal, and patient satisfaction. The study aims to address the limitations of JP drains, which often lead to prolonged recovery times and inconsistent suction. Follow-up assessments will track clinical data and patient experiences throughout the recovery process.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-65 with a breast cancer diagnosis requiring bilateral mastectomy and immediate implant-based reconstruction.
Not a fit: Patients with prior radiation to the breast or those currently undergoing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery experiences and outcomes for patients undergoing breast reconstruction.
How similar studies have performed: While the use of innovative drain systems is gaining interest, this specific comparison of the Interi Drain and JP drain is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Palo Alto, California
- Stanford Hospital and Clinics — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Kassandra Carrion
- Email: kcarrion@stanford.edu
- Phone: (949) 521-0474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.