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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospitals of Derby and Burton NHS Foundation Trust Academic / other |
| Locations | 5 sites (Derby and 4 other locations) |
| Status | Recruiting |
| Started | November 2, 2023 |
| Main results expected | April 30, 2026 |
| Study ends | April 30, 2026 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT05449691 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
- Study coordinator: Amit Goyal, MS, MD, FRCS
- Email: amit.goyal@nhs.net
- Phone: 01332786958
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.