Biological Matrices Versus Synthetic Meshes

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.

Trial Details

NCT ID
NCT05449691
Phase
NA
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • One-stage immediate breast reconstruction
Locations (sample)
  • Derby, United Kingdom|52.92277,-1.47663
  • High Wycombe, United Kingdom|51.62907,-0.74934
  • Hull, United Kingdom|53.7446,-0.33525
  • Leicester, United Kingdom|52.6386,-1.13169
  • Nottingham, United Kingdom|52.9536,-1.15047

Key Eligibility Criteria

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

For full eligibility, visit ClinicalTrials.gov.

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