Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh
Launched by UNIVERSITY OF OXFORD · Oct 30, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 ...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Women \> 18 years
- • Participant is able and willing to give informed consent for participation in the trial
- • Eligible for immediate prepectoral implant-based breast reconstruction with implant or expander with mesh (biologic or synthetic) for cancer treatment or risk reduction surgery.
- • In the Investigator's opinion, can comply with all trial requirements.
- Exclusion Criteria:
- The participant may not enter the trial if any of the following apply:
- • Participant is pregnant, lactating or planning pregnancy during the trial
- • Patient refusal
- • Delayed breast reconstruction post simple mastectomy
About University Of Oxford
The University of Oxford, a prestigious institution renowned for its excellence in research and education, serves as a leading clinical trial sponsor dedicated to advancing medical science and improving patient care. With a rich history of innovation and a multidisciplinary approach, the university leverages its extensive expertise in various fields, including medicine, public health, and biomedical research, to conduct rigorous clinical trials. Collaborating with healthcare professionals, industry partners, and regulatory bodies, the University of Oxford aims to translate groundbreaking research findings into effective therapies and interventions, contributing to the global effort of enhancing health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oxford, Oxfordshire, United Kingdom
Patients applied
Trial Officials
Ms Rachel Rolph, MBBS MA FRCS
Principal Investigator
University of Oxford
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported