Comparing biological and synthetic meshes for breast reconstruction
BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospitals of Derby and Burton NHS Foundation Trust Academic / other |
| Locations | 5 sites (Derby and 4 other locations) |
| Trial ID | NCT05449691 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are undergoing mastectomy and immediate one-stage mesh-assisted implant breast reconstruction.
Not a fit: Patients seeking revision or delayed reconstruction surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient satisfaction and outcomes in breast reconstruction surgeries.
How similar studies have performed: 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.
Eligibility criteria
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 this trial is running
Derby and 4 other locations
- 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
- Study coordinator: Amit Goyal, MS, MD, FRCS
- Email: amit.goyal@nhs.net
- Phone: 01332786958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.