Biological Matrices Versus Synthetic Meshes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: One-stage immediate breast reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biological Matrix<br>Participants will undergo immediate breast reconstruction using biological matrix and implant | Procedure: One-stage immediate breast reconstruction<br>* One-stage mesh assisted implant breast reconstruction<br>|
| Experimental: Synthetic Mesh<br>Participants will undergo immediate breast reconstruction using synthetic mesh and implant | Procedure: One-stage immediate breast reconstruction<br>* One-stage mesh assisted implant breast reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician acceptance | Proportion of eligible women offered the trial | 2 years | 
| Patient acceptance | Proportion of women offered the trial who participate in the trial | 2 years | 
| Recruitment rate | Number of patient recruited per year per site | 2 years | 
| Compliance with allocated intervention | Number of patients not complying with randomisation allocation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, mesh, acellular dermal matrix, synthetic mesh, breast cancer, patient reported outcome