Clinical trial NCT05449691: Biological Matrices Versus Synthetic Meshes
Official title: BIOSYM - a Feasibility Randomised Controlled Trial Comparing Biological Matrices with Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast reconstruction
mesh
acellular dermal matrix
synthetic mesh
breast cancer
patient reported outcome
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Clinician acceptance
timeFrame: 2 years
measure: Patient acceptance
timeFrame: 2 years
measure: Recruitment rate
timeFrame: 2 years
measure: Compliance with allocated intervention
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Wycombe
country: United Kingdom
facility: Wycombe Hospital
Study officials:
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
name: Amit Goyal, MS, MD, FRCS
role: STUDY_CHAIR
References: