Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05449691

Biological Matrices Versus Synthetic Meshes

Led by University Hospitals of Derby and Burton NHS Foundation Trust · Updated on 2025-09-10

60

Participants Needed

5

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Biological Matrices Versus Synthetic Meshes

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female age 63 18
  • Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment
Not Eligible

You will not qualify if you...

  • Revision reconstruction surgery
  • Delayed reconstruction surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, United Kingdom, DE22 3NE

Actively Recruiting

2

Wycombe Hospital

High Wycombe, United Kingdom

Actively Recruiting

3

Castle Hill Hospital

Hull, United Kingdom

Actively Recruiting

4

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Actively Recruiting

5

Nottingham City Hospital

Nottingham, United Kingdom

Actively Recruiting

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Research Team

A

Amit Goyal, MS, MD, FRCS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Biological Matrices Versus Synthetic Meshes | DecenTrialz