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Biological Matrices Versus Synthetic Meshes

Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

NCT ID: NCT05449691

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
One-stage immediate breast reconstruction (procedure)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
One-stage immediate breast reconstruction — procedure: One-stage mesh assisted implant breast reconstruction
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at breast reconstruction for women with breast cancer who are having breast removal surgery (a mastectomy). It compares two kinds of mesh used to support a breast implant when the reconstruction is done straight after the mastectomy: a biological mesh and a synthetic (man-made) mesh. The study is sponsored by University Hospitals of Derby and Burton National Health Service (NHS) Foundation Trust.

Who can take part

  • Women aged 18 or over.
  • Women having a mastectomy with breast reconstruction in the same operation, using an implant supported by mesh, as their planned standard treatment.

Who may not be able to

  • Women having surgery to redo or correct a previous breast reconstruction (revision surgery).
  • Women having breast reconstruction at a later date, rather than at the same time as the mastectomy (delayed reconstruction).

What taking part involves

  • • Breast removal surgery (a mastectomy).
  • • Breast reconstruction in the same operation, done in one stage, using an implant supported by mesh.
  • • Receiving either a biological mesh or a synthetic (man-made) mesh, which the study compares.

Time commitment: Taking part involves breast removal surgery and reconstruction with an implant and mesh in the same operation; the number of visits and how long the study lasts are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
60
Started
2023-11-02
Last checked
2025-09

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer
  • • NA - 60 participants
  • • In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast cancer
  • • Female only

Where?

  • • Derby - University Hospitals of Derby and Burton NHS Foundation Trust
  • • High Wycombe - Wycombe Hospital
  • • Hull - Castle Hill Hospital
  • • Leicester - University Hospitals of Leicester NHS Trust
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Breast Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

What the study is looking for

  • ✓Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as...

Who cannot take part

  • ✗Revision reconstruction surgery Delayed reconstruction surgery
See the full 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 Is This Study? (5 UK sites)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby DE22 3NE, United Kingdom

Recruiting
Site contact (verified)

Wycombe Hospital

High Wycombe, United Kingdom

Recruiting
Site contact (verified)
Fiona Tsang-Wrightfiona.tsangwright@nhs.net

Castle Hill Hospital

Hull, United Kingdom

Recruiting
Site contact (verified)
Kartikae Groverkartikaegrover@nhs.net

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Recruiting
Site contact (verified)

Nottingham City Hospital

Nottingham, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Amit Goyal, MS, MD, FRCS

Sponsor contact

CONTACT

01332786958 amit.goyal@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-09