BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment
Locations
Other Locations
United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
RECRUITING
Derby
Wycombe Hospital
RECRUITING
High Wycombe
Castle Hill Hospital
RECRUITING
Hull
University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Nottingham City Hospital
RECRUITING
Nottingham
Contact Information
Primary
Amit Goyal, MS, MD, FRCS
amit.goyal@nhs.net
01332786958
Time Frame
Start Date: 2023-11-02
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 60
Treatments
Active_comparator: Biological Matrix
Participants will undergo immediate breast reconstruction using biological matrix and implant
Experimental: Synthetic Mesh
Participants will undergo immediate breast reconstruction using synthetic mesh and implant
Related Therapeutic Areas
Sponsors
Leads: University Hospitals of Derby and Burton NHS Foundation Trust