Biological Matrices Versus Synthetic Meshes
Recruiting · NCT05449691 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
One-stage immediate breast reconstruction
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
5 locations listed.
- 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