Biological Matrices Versus Synthetic Meshes (BIOSYM)
BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. Surgeons often use a sheet of mesh to cover the implant as standard treatment. It acts like an internal bra and supports the implant and re-creates a natural looking breast.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amit Goyal, MS, MD, FRCS
- Phone Number: 01332786958
- Email: amit.goyal@nhs.net
Study Locations
-
-
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Derby, United Kingdom, DE22 3NE
- Recruiting
- University Hospitals of Derby and Burton NHS Foundation Trust
-
Contact:
- Emanuele Garreffa
-
Contact:
- Email: emanuele.garreffa@nhs.net
-
High Wycombe, United Kingdom
- Recruiting
- Wycombe Hospital
-
Contact:
- Fiona Tsang-Wright
- Email: fiona.tsangwright@nhs.net
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Hull, United Kingdom
- Recruiting
- Castle Hill Hospital
-
Contact:
- Kartikae Grover
- Email: kartikaegrover@nhs.net
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Leicester, United Kingdom
- Recruiting
- University Hospitals of Leicester NHS Trust
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Contact:
- Monika Kaushik
-
Contact:
- Email: monika.kaushik@uhl-tr.nhs.uk
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Nottingham, United Kingdom
- Recruiting
- Nottingham City Hospital
-
Contact:
- Hazem Khout
- Email: Hazem.Khout@nuh.nhs.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Biological Matrix
Participants will undergo immediate breast reconstruction using biological matrix and implant
|
One-stage mesh assisted implant breast reconstruction
|
|
Experimental: Synthetic Mesh
Participants will undergo immediate breast reconstruction using synthetic mesh and implant
|
One-stage mesh assisted implant breast reconstruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician acceptance
Time Frame: 2 years
|
Proportion of eligible women offered the trial
|
2 years
|
|
Patient acceptance
Time Frame: 2 years
|
Proportion of women offered the trial who participate in the trial
|
2 years
|
|
Recruitment rate
Time Frame: 2 years
|
Number of patient recruited per year per site
|
2 years
|
|
Compliance with allocated intervention
Time Frame: 2 years
|
Number of patients not complying with randomisation allocation
|
2 years
|
Collaborators and Investigators
Investigators
- Study Chair: Amit Goyal, MS, MD, FRCS, University Hospitals of Derby and Burton NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 315581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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