Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2023-11-02
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
NCT01823107
Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction
NCT01310075
Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh
NCT06112977
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
NCT05031962
Assessment of Safety & Efficacy of Light Weight Breast Implant
NCT01874652
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Natural(biological) or man-made (synthetic) meshes are used routinely in the NHS. Biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. Synthetic meshes are made from net-like fabric and cost less. The choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. The two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare.
A large UK review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. This suggests that both may be equally safe in the short-term. However, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. This is important as some side-effects only appear later after surgery. Clinicians do not know how outcomes impact on patients' health and well-being.
The best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. Investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. This type of study would tell us how good each mesh is and if they are safe long-term.
Before starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Biological Matrix
Participants will undergo immediate breast reconstruction using biological matrix and implant
One-stage immediate breast reconstruction
One-stage mesh assisted implant breast reconstruction
Synthetic Mesh
Participants will undergo immediate breast reconstruction using synthetic mesh and implant
One-stage immediate breast reconstruction
One-stage mesh assisted implant breast reconstruction
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
One-stage immediate breast reconstruction
One-stage mesh assisted implant breast reconstruction
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Amit Goyal
Chief Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amit Goyal, MS, MD, FRCS
Role: STUDY_CHAIR
University Hospitals of Derby and Burton NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Emanuele Garreffa
Role: primary
Role: backup
Monika Kaushik
Role: primary
Role: backup
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
315581
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.