NCT05449691 Biological Matrices Versus Synthetic Meshes
| NCT ID | NCT05449691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals of Derby and Burton NHS Foundation Trust |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-11-02 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Amit Goyal, MS, MD, FRCS
STUDY CHAIR
University Hospitals of Derby and Burton NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT05449691 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05449691 currently recruiting?
Yes, NCT05449691 is actively recruiting participants. Contact the research team at amit.goyal@nhs.net for enrollment information.
Where is the NCT05449691 trial being conducted?
This trial is being conducted at Derby, United Kingdom, High Wycombe, United Kingdom, Hull, United Kingdom, Leicester, United Kingdom and 1 additional location.
Who is sponsoring the NCT05449691 clinical trial?
NCT05449691 is sponsored by University Hospitals of Derby and Burton NHS Foundation Trust. The principal investigator is Amit Goyal, MS, MD, FRCS at University Hospitals of Derby and Burton NHS Foundation Trust. The trial plans to enroll 60 participants.
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