Breast CancerBIOSYMNCT05449691
Biological Matrices Versus Synthetic Meshes
A study testing One-stage immediate breast reconstruction in people with Breast Cancer, run by University Hospitals of Derby and Burton NHS Foundation Trust at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- One-stage immediate breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 2 Nov 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment
Who cannot join
- Revision reconstruction surgery Delayed reconstruction surgery
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE
Emanuele Garreffa
emanuele.garreffa@nhs.net
- Recruiting
Wycombe Hospital
High Wycombe
Fiona Tsang-Wright, fiona.tsangwright@nhs.net
- Recruiting
Castle Hill Hospital
Hull
Kartikae Grover, kartikaegrover@nhs.net
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester
Monika Kaushik
monika.kaushik@uhl-tr.nhs.uk
- Recruiting
Nottingham City Hospital
Nottingham
Hazem Khout, Hazem.Khout@nuh.nhs.uk
About this study
Official title: BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
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.
Read the detailed description
Immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. Surgeons often use a sheet of mesh to cover the implant as standard treatment. It acts like an internal bra and supports the implant and re-creates a natural looking breast.
Natural(biological) or man-made (synthetic) meshes are used routinely in the NHS. Biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. Synthetic meshes are made from net-like fabric and cost less. The choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. The two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare.
A large UK review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. This suggests that both may be equally safe in the short-term. However, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. This is important as some side-effects only appear later after surgery. Clinicians do not know how outcomes impact on patients' health and well-being.
The best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. Investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. This type of study would tell us how good each mesh is and if they are safe long-term.
Before starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.
- Conditions
- Breast Cancer
- Being tested
- One-stage immediate breast reconstruction
- Keywords
- breast reconstruction, mesh, acellular dermal matrix, synthetic mesh, breast cancer, patient reported outcome
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-stage immediate breast reconstructionProcedure or surgery
One-stage mesh assisted implant breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Biological Matrix | Active comparator | Participants will undergo immediate breast reconstruction using biological matrix and implant Receives: Procedure: One-stage immediate breast reconstruction |
| Synthetic Mesh | Experimental | Participants will undergo immediate breast reconstruction using synthetic mesh and implant Receives: Procedure: One-stage immediate breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician acceptance
Proportion of eligible women offered the trial
Measured: 2 years
Patient acceptance
Proportion of women offered the trial who participate in the trial
Measured: 2 years
Recruitment rate
Number of patient recruited per year per site
Measured: 2 years
Compliance with allocated intervention
Number of patients not complying with randomisation allocation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start2 Nov 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Amit Goyal, University Hospitals of Derby and Burton NHS Foundation Trust
- Investigators
- Amit Goyal, MS, MD, FRCS, Study chair, University Hospitals of Derby and Burton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449691
- Sponsor's protocol ID
- 315581
- Acronym
- BIOSYM
- Status last verified
- Sep 2025
- First submitted
- 4 Jul 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05449691
- Acronym / sponsor ID
- BIOSYM / 315581
- Conditions
- Breast Cancer
- Keywords
- breast reconstruction, mesh, acellular dermal matrix, synthetic mesh, breast cancer, patient reported outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. Surgeons often use a sheet of mesh to cover the implant as standard treatment. It acts like an internal bra and supports the implant and re-creates a natural looking breast.
Natural(biological) or man-made (synthetic) meshes are used routinely in the NHS. Biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. Synthetic meshes are made from net-like fabric and cost less. The choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. The two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare.
A large UK review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. This suggests that both may be equally safe in the short-term. However, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. This is important as some side-effects only appear later after surgery. Clinicians do not know how outcomes impact on patients' health and well-being.
The best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. Investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. This type of study would tell us how good each mesh is and if they are safe long-term.
Before starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological Matrix | Active comparator | Procedure: One-stage immediate breast reconstructionParticipants will undergo immediate breast reconstruction using biological matrix and implant |
| Synthetic Mesh | Experimental | Procedure: One-stage immediate breast reconstructionParticipants will undergo immediate breast reconstruction using synthetic mesh and implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment
Key exclusion criteria (1 listed)
- Revision reconstruction surgery Delayed reconstruction surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-stage immediate breast reconstructionOne-stage mesh assisted implant breast reconstruction | Procedure or surgery | Biological Matrix, Synthetic Mesh |
Primary outcome
Clinician acceptance
Time frame: 2 years
Proportion of eligible women offered the trial
Patient acceptance
Time frame: 2 years
Proportion of women offered the trial who participate in the trial
Recruitment rate
Time frame: 2 years
Number of patient recruited per year per site
Compliance with allocated intervention
Time frame: 2 years
Number of patients not complying with randomisation allocation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Goyal, MS, MD, FRCS study chair
University Hospitals of Derby and Burton NHS Foundation Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-stage immediate breast reconstruction in people with Breast Cancer, run by University Hospitals of Derby and Burton NHS Foundation Trust at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Goyal, MS, MD, FRCS (01332786958, amit.goyal@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician acceptance (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.