BIOSYM

Overview

Randomised trial comparing Biological Matrices with Synthetic Meshes

In this phase III feasibility randomised controlled trial, 60 women undergoing immediate one-stage implant reconstruction will be randomly allocated to receive biological (ADM) 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.

Patients will have follow-up visits at 3- and 6-months post-surgery, during which complications and patient-reported outcomes will be recorded using the Breast-Q and EQ-5D-5L questionnaires.

Objectives

To assess patient and clinician acceptance, recruitment rate, and compliance with randomly allocated type of mesh. We will evaluate appropriateness and completeness of data on proposed future main study outcomes. The standard deviation (SD) of patient reported ‘satisfaction with breasts’ score on Breast Q questionnaire will inform sample size calculations for the main study.

Feasibility study will assess:

• ·         Clinician acceptance: Proportion of eligible women offered the trial
• ·         Patient acceptance: Proportion of women offered the trial who participate in the trial
• ·         Recruitment rate (average per year / site)
• ·         Completeness of data on proposed definitive trial study outcomes
• ·         Compliance with allocated type of mesh

The follow-on main study will assess long-term (5 years) patient reported ‘satisfaction with breasts’ measured using Breast Q questionnaire, quality of life measured using Breast Q and EQ-5D-5L questionnaires, complications and economic evaluation.

Inclusion/ exclusion criteria

Inclusion Criteria

Eligible participants will be/should have:

•    Female age ≥ 18

•    Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment

Exclusion Criteria

Participants will be excluded if they have any one of the following:

•    Revision reconstruction surgery

•    Delayed reconstruction surgery

Planned sample size

n=60

Total number of sites planned - 5

Timeline

Planned Recruitment End Date: 30 November 2025