Breast reconstruction Surgery
Conditions
Interventions
The study is a single-arm phase II prospective cohort study to assess the safety and efficacy of the FORTIVA surgical mesh in patients undergoing immediate implant-based breast reconstruction. The stu
Sponsors
Royal Liverpool and Broadgreen University Hospital NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women over the age of 18 undergoing mastectomy for invasive or pre-invasive breast cancer or risk reduction 2. Elect to undergo a sub-pectoral or pre-pectoral immediate implant-based reconstruction with mesh
Exclusion criteria
Exclusion criteria: Patients undergoing: 1. Revisional surgery 2. Delayed breast reconstruction 3. Previous breast or mantle radiotherapy 4. Patients who are allergic to pork or unwilling to have a porcine product 5. Patients unable or unwilling to give informed consent 6. Patients considered by their surgeon to be unsuitable for mesh reconstruction 7. Patients who currently smoke cigarettes or e-cigarettes 8. Patients with a BMI of 35 or above 9. Patients in whom it is anticipated that an implant volume of greater than 500cc will be required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and effectiveness of Fortiva mesh in implant-based breast reconstruction measured by recording implant loss rate at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The safety and efficacy of Fortiva mesh in implant-based breast reconstruction measured by: 1.1. Implant loss rate at 18 months 1.2. Complications of implant-based breast reconstruction with Fortiva mesh at 3 months 1.3. Complications of implant-based breast reconstruction with Fortiva mesh at 18 months 2. Product handling and surgeon experience of using Fortiva in subpectoral and prepectoral reconstruction measured using a surgeon self-report feedback form | — |
Countries
England, United Kingdom
Outcome results
None listed