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Biological Matrices Versus Synthetic Meshes

RECRUITINGN/ASponsored by University Hospitals of Derby and Burton NHS Foundation Trust
Actively Recruiting
PhaseN/A
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust
Started2023-11-02
Est. completion2026-04-30
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05449691

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. 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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

Breast CancerCancer

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