Clinical trial Recruiting at 5 sites Interventional Ages 18 and up Women only

Comparing biological and synthetic meshes for breast reconstruction

Official title: BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction

Run by University Hospitals of Derby and Burton NHS Foundation Trust · NCT05449691 · Data updated 2026-11-12

This study is testing whether biological or synthetic mesh works better for women getting breast reconstruction after mastectomy to see which one helps them feel more comfortable and satisfied.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment60 (estimated)
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust
Academic / other
Locations5 sites (Derby and 4 other locations)
StatusRecruiting
StartedNovember 2, 2023
Main results expectedApril 30, 2026
Study endsApril 30, 2026
Registry record updatedSeptember 10, 2025
Trial IDNCT05449691 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 18 and older who are undergoing mastectomy and immediate one-stage mesh-assisted implant breast reconstruction.

Probably not a fit

Patients seeking revision or delayed reconstruction surgery will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study involves 60 women undergoing immediate breast reconstruction after mastectomy for breast cancer. Participants will be randomly assigned to receive either biological or synthetic mesh to support breast implants, with follow-up for 6 months to assess comfort with the allocation process. The study aims to evaluate patient satisfaction, quality of life, complications, and costs over a longer period in future research. The goal is to better understand the long-term safety and acceptability of both types of meshes.

Why it matters

Potential benefit: If successful, this study could improve patient satisfaction and outcomes in breast reconstruction surgeries.

How similar studies have gone: Previous studies have suggested that both biological and synthetic meshes may be equally safe in the short term, but this study aims to provide more comprehensive long-term data.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment

Exclusion Criteria:

Revision reconstruction surgery Delayed reconstruction surgery

Where it's running

  • University Hospitals of Derby and Burton NHS Foundation Trust
    Derby, United Kingdom
    Recruiting
  • Wycombe Hospital
    High Wycombe, United Kingdom
    Recruiting
  • Castle Hill Hospital
    Hull, United Kingdom
    Recruiting
  • University Hospitals of Leicester NHS Trust
    Leicester, United Kingdom
    Recruiting
  • Nottingham City Hospital
    Nottingham, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.