A study evaluating the safety and effectiveness of Fortiva mesh in immediate implant-based breast reconstruction

Plain English Summary

Background and study aims
Breast reconstruction is offered to patients having a mastectomy and can be done at the same operation (an immediate reconstruction) or at a later date (delayed reconstruction). Silicone implants are the most common way of reconstructing breasts in patients having immediate reconstruction. This is commonly done using a mesh. Meshes can be made from man-made material (synthetic mesh) or from human or animal tissue that has been treated (biological mesh). A pocket is created to hold the implant in place underneath the skin. The upper part of the pocket is often formed by lifting the pectoral (chest wall) muscle. The lower part of the implant is supported by a mesh. This is called a sub-pectoral reconstruction. Another alternative is to make the whole pocket from mesh and place this on top of the muscle, known as pre-pectoral reconstruction. This is a newer technique and is also being assessed in this study. Many new mesh products continue to be developed to try and improve the results of implant reconstructions. These products need to be assessed to ensure that they are safe and effective. The aim of this study is to monitor and collect information about a new mesh designed for breast reconstruction with implants.

Who can participate?
Women over the age of 18 undergoing mastectomy for invasive or pre-invasive breast cancer or risk reduction, who elect to undergo a sub-pectoral or pre-pectoral immediate implant-based reconstruction with mesh

What does the study involve?
Information about complications that occur as a result of the surgery is collected. The main way of measuring the safety of the mesh is the number of patients who need to have their implant removed because of a complication from the surgery. Details of complications after the surgery are collected at 3 months and 18 months. These are compared with results from a group of 2000 patients who have had breast reconstruction with mesh and implants. Patients and surgeons are asked for their feedback on the result of the operation.

What are the possible benefits and risks of participating?
There is no direct benefit from taking part. This study will provide important safety information for future patients. If the Fortiva mesh is shown to be as safe as other meshes there may be a cost saving for the NHS. There is a risk that the Fortiva mesh may lead to more problems or complications compared with other meshes. The researchers plan to stop and check this after the first 46 patients have been enrolled in the study to look at this. The surgeons taking part in this study must have shown that they have low complication rates from breast implant surgery in order to use the new mesh.

Where is the study run from?
1. Hampshire Hospitals NHS Foundation Trust (UK)
2. Brighton And Sussex University Hospitals NHS Trust (UK)
3. The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
4. Nottingham University Hospitals NHS Trust (UK)
5. Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust (UK)
6. Berkshire Healthcare NHS Foundation Trust (UK)
7. Barts Health NHS Trust (UK)
8. Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)
9. Manchester University NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
July 2019 to July 2022

Who is funding the study?
1. Association of Breast Surgery (UK)
2. National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Helen Scott
hscott@liv.ac.uk

Trial website

Type

Scientific

Primary contact

Ms Helen Scott

ORCID ID

Contact details

Trial Manager
Liverpool Clinical Trials Centre
Block C
Waterhouse Building
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0151 794 8209
hscott@liv.ac.uk

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 42171, IRAS 261822

Scientific title

A Mesh SAfety Platform for Immediate Implant-based BReAst Reconstruction (MAP-BRA) - Project 1. A multicentre prospective cohort study to evaluate the safety and effectiveness of Fortiva porcine acellular dermal matrix in immediate implant-based breast reconstruction

Acronym

MAP-BRA -1

Study hypothesis

The purpose of this study is to monitor and collect information about a new mesh designed for breast reconstruction with implants.

Ethics approval

Approved 23/07/2019, North West – Liverpool Central Research Ethics Committee (3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; Tel: +44 (0)207 104 8196; Email: nrescommittee.northwest-liverpoolcentral@nhs.net), ref: 19/NW/0352

Study design

Non-randomised; Both; Design type: Treatment, Surgery, Cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Breast reconstruction

Intervention

The study is a single-arm phase II prospective cohort study to assess the safety and efficacy of the FORTIVA surgical mesh in patients undergoing immediate implant-based breast reconstruction. The study will recruit women who have elected to undergo a breast construction using as surgical mesh. Instead of the normal practice of the surgeon using their own or their hospitals own choice of mesh the surgeon will use the FORTIVA surgical mesh for the procedure. The same mesh will be used on all patient enrolled on the study.

Each patient will be on study for a period of 18 months. The patients will be enrolled onto the trial after they have received the patient information sheet had time to discuss the options with their clinical care team and their friend and family and having provided written informed consent. The patient will then undergo their breast surgery (using the FORTIVA mesh), in-patient recovery and out-patient follow-up as per standard of care. Additional data compared to standard of care will be collected at these visits, including baseline characteristics, details of the operation, pain assessments and details of any complications. Patients will then be asked to attend for three additional study visits over and above the standard of care at 30 days, 3 months and 18 months post-surgery. At these visits, the team will collect information on pain and complications. All study visits will take place in the tertiary care centre and will be conducted by the direct clinical care of the patient supported by research nurses as required.

The study will also ask the surgeons performing the procedure to complete a surgical questionnaire for each patient. As the main aim of the study is to estimate an acceptable implant loss rate and not to make direct comparisons with other treatments. This Simon 2 stage design was chosen as a well-established methodology for Phase II study. The study will recruit to a maximum of 79 patients. An assessment will be done after 46 patients have reached their 3 months follow-up. Recruitment will continue only if 5 or fewer patients have had an implant loss. If ≥ 6 implant losses are observed, the study will stop due to an unacceptable implant loss rate. At the point of the final analysis, the mesh will be deemed safe and suitable for further investigation.

Direct comparisons and randomisation are very difficult in this setting as there is no standard of care mesh or surgical method for the procedures. Surgeons conduct operations based on their experience and clinical decision making. Therefore as a secondary outcome the researchers will make comparisons with the patients recruited into the iBRA study, a prospective cohort of 2000 patients undergoing IBBR at over 70 centres between 2014 and 2016. Here comparisons will be made on a matched basis to give some indication of a direct comparison of FORTIVA and other approaches. The researchers plan to recruit patients over a 36-month period from 10 experience surgical centres across the UK.

Intervention type

Device

Phase

Phase II

Drug names

Fortiva surgical mesh

Primary outcome measure

The safety and effectiveness of Fortiva mesh in implant-based breast reconstruction measured by recording implant loss rate at 3 months

Secondary outcome measures

1. The safety and efficacy of Fortiva mesh in implant-based breast reconstruction measured by:
1.1. Implant loss rate at 18 months
1.2. Complications of implant-based breast reconstruction with Fortiva mesh at 3 months
1.3. Complications of implant-based breast reconstruction with Fortiva mesh at 18 months
2. Product handling and surgeon experience of using Fortiva in subpectoral and prepectoral reconstruction measured using a surgeon self-report feedback form

Overall trial start date

01/07/2019

Overall trial end date

01/07/2022

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Women over the age of 18 undergoing mastectomy for invasive or pre-invasive breast cancer or risk reduction
2. Elect to undergo a sub-pectoral or pre-pectoral immediate implant-based reconstruction with mesh

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 79; UK Sample Size: 79

Participant exclusion criteria

Patients undergoing:
1. Revisional surgery
2. Delayed breast reconstruction
3. Previous breast or mantle radiotherapy
4. Patients who are allergic to pork or unwilling to have a porcine product
5. Patients unable or unwilling to give informed consent
6. Patients considered by their surgeon to be unsuitable for mesh reconstruction
7. Patients who currently smoke cigarettes or e-cigarettes
8. Patients with a BMI of 35 or above
9. Patients in whom it is anticipated that an implant volume of greater than 500cc will be required

Recruitment start date

01/02/2020

Recruitment end date

01/11/2020

Countries of recruitment

United Kingdom

Trial participating centre

Hampshire Hospitals NHS Foundation Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

Brighton And Sussex University Hospitals NHS Trust
Royal Sussex County Hospital Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital Freeman Road High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Trust Headquarters Queens Medical Centre Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster Royal Infirmary Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

Trial participating centre

Berkshire Healthcare NHS Foundation Trust
Fitzwilliam House Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom

Trial participating centre

Barts Health NHS Trust
The Royal London Hospital Whitechapel
London
E1 1BB
United Kingdom

Trial participating centre

Royal Liverpool and Broadgreen University Hospitals NHS Trust
Royal Liverpool University Hospital Prescot Street
Liverpool
L7 8XP
United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Cobbett House Oxford Road
Manchester
M13 9WL
United Kingdom

Organisation

Royal Liverpool and Broadgreen University Hospital NHS Trust

Sponsor details

c/o Debbie Atkinson
4th Floor Linda McCartney Building
Liverpool
L7 8XP
United Kingdom
+44 (0)1517063702
RGT@rlbuht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.rlbuht.nhs.uk/Pages/RoyalHome.aspx

Funder type

Government

Funder name

Association of Breast Surgery

Alternative name(s)

ABS

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

1. Study protocol not currently publicly available, please contact mapbra@liverpool.ac.uk for access to these documents
2. Peer-reviewed scientific journals
3. Conference presentation
4. Publication on website

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/07/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

13/01/2020: Trial's existence confirmed by the NIHR.