Trial Design:
Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery.
Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).
Planned Trial Period:
The overall period of the trial is:
12 months recruitment, 3 months follow-up and 6 months data analysis and final reporting of results.
Trial Participants:
Women over 18 years old eligible for elective immediate prepectoral implant-based breast reconstruction with mesh for cancer treatment or risk reduction surgery
Intervention:
Immediate prepectoral implant-based (implant or expander) breast reconstruction without surgical mesh (ADM or synthetic).
Comparator:
Immediate prepectoral implant- based (implant or expander) breast reconstruction with surgical mesh (ADM or synthetic) (standard of care).
