Biological Matrices Versus Synthetic Meshes
BIOSYM
BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
1 other identifier
interventional
60
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Nov 2023
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedStudy Start
First participant enrolled
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedSeptember 10, 2025
September 1, 2025
2.5 years
July 4, 2022
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Clinician acceptance
Proportion of eligible women offered the trial
2 years
Patient acceptance
Proportion of women offered the trial who participate in the trial
2 years
Recruitment rate
Number of patient recruited per year per site
2 years
Compliance with allocated intervention
Number of patients not complying with randomisation allocation
2 years
Study Arms (2)
Biological Matrix
ACTIVE COMPARATORParticipants will undergo immediate breast reconstruction using biological matrix and implant
Synthetic Mesh
EXPERIMENTALParticipants will undergo immediate breast reconstruction using synthetic mesh and implant
Interventions
One-stage mesh assisted implant breast reconstruction
Eligibility Criteria
You may qualify if:
- Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment
You may not qualify if:
- Revision reconstruction surgery Delayed reconstruction surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE, United Kingdom
Wycombe Hospital
High Wycombe, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amit Goyal, MS, MD, FRCS
University Hospitals of Derby and Burton NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single blind masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator
Study Record Dates
First Submitted
July 4, 2022
First Posted
July 8, 2022
Study Start
November 2, 2023
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share