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RECRUITING
NCT05449691
NA

Biological Matrices Versus Synthetic Meshes

Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official title: BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-11-02

Completion Date

2026-04-30

Last Updated

2025-09-10

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

One-stage immediate breast reconstruction

One-stage mesh assisted implant breast reconstruction

Locations (5)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, United Kingdom

Wycombe Hospital

High Wycombe, United Kingdom

Castle Hill Hospital

Hull, United Kingdom

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom