A study evaluating the safety and effectiveness of Fortiva mesh in immediate implant-based breast reconstructio

Phase 2

• Conditions: Breast reconstruction; Surgery

• Registration Number: ISRCTN16902075
• Lead Sponsor: Royal Liverpool and Broadgreen University Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-14
• Last Update Posted: 19 September 2022
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 79

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified