Breast NeoplasmsPOBRAD-MNCT02557906
Evaluating Outcomes of Immediate Breast Reconstruction (POBRAD-M)
A study testing Breast reconstruction - implant and an ADM (SurgiMend), Breast reconstruction- autologous tissue and Breast reconstruction- implant + dermal sling/LD flap in people with Breast Neoplasms and Breast Diseases, run by King's College London at 6 sites in United Kingdom.
Trial summary
Some women with breast cancer have their whole breast removed as part of their treatment (mastectomy). Of these women, around 31% have more surgery to create a new breast.There are two main ways to create a new breast(i)using tissue from elsewhere on the body ("autologous" reconstruction )or (ii)using a silicone… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Diseases
- What is being tested?
- Breast reconstruction - implant and an ADM (SurgiMend), Breast reconstruction- autologous tissue and Breast reconstruction- implant + dermal sling/LD flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Jul 2014to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent given
- Unilateral or bilateral mastectomy (therapeutic, contra lateral or prophylactic)
- Immediate reconstruction;
- Suitable for immediate implant reconstruction with ADM
Who cannot join
- Patients unable to provide informed consent to participate in trial
- Patients unavailable for follow-up
- Not eligible for immediate breast reconstruction using an ADM
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Frimley Park Hospitals NHS Foundation Trust
Frimley
Leeds Teaching Hospitals
Leeds
Department of Research Oncology, King's College London
London, SE1 9RT
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Royal Cornwall Hospital
Truro
Royal Hampshire County Hospital
Winchester, Hampshire
About this study
Official title: Prospective, Multi-centre, Observational Trial Evaluating Outcomes of Immediate Breast Reconstruction Using an Implant and Acellular Dermal Matrix (SurgiMend) or Autologous Tissue
Some women with breast cancer have their whole breast removed as part of their treatment (mastectomy). Of these women, around 31% have more surgery to create a new breast.There are two main ways to create a new breast(i)using tissue from elsewhere on the body ("autologous" reconstruction )or (ii)using a silicone implant.
In recent years, it has been reported that by using a material called an "acellular dermal matrix" (ADM) the results of breast reconstruction surgery using an implant can be improved. ADMs are materials which originally come from animal or human skin. They act like a sling, supporting the lower part of an implant beneath the skin.
Read more
Although ADMs have been approved for used in breast reconstruction and are safe, there is very little high quality evidence to back up their reported benefits, and some studies have suggested their use may in fact increase complications.
The main purpose of this study is to find out what the actual risks and benefits of using an ADM in breast reconstruction surgery are. The investigators will follow the progress of women who have an implant based reconstruction to observe if participants develop problems; what those problems are and how participants feel about the results of their surgery. The investigators also follow the progress of women who undergo autologous reconstruction or alternative reconstructive techniques using an implant for the same reasons.
Read the detailed description
Despite the widespread adoption of acellular dermal matrices (ADMs) in breast reconstruction, there is limited prospective or high quality evidence on the outcomes of their use. The majority of studies on ADM are poor quality retrospective cohort studies with ill-defined, non-standardised outcome measures and heterogeneous patient populations. Recent systematic reviews have raised concerns of increased infection and seroma rates associated with ADM use which, if correct, may negate their reported advantages. Furthermore there is little high quality evidence to confirm the benefits associated with their use such as improved aesthetic outcomes.
The POBRAD-M is a prospective, multicentre trial which will evaluate the early and late outcomes of immediate breast reconstruction using either an implant and ADM, autologous tissue or an alternative implant-based technique. All participants must have been deemed suitable at the outset for implant based reconstruction with an ADM irrespective of their final procedure choice. All participants will be followed up at 30 days, 3 months and 12 months to record the incidence of complications (to include implant loss, infection, seroma, haematoma and skin necrosis). Additionally Patient Reported Outcomes measures using the BREAST-Q questionnaire will be determined at 30 days and 12 months, and aesthetic outcome will be determined by panel assessment of post-operative photographs at 12 months post-operatively.
- Conditions
- Breast Neoplasms, Breast Diseases
- Being tested
- Breast reconstruction - implant and an ADM (SurgiMend), Breast reconstruction- autologous tissue, Breast reconstruction- implant + dermal sling/LD flap
- Keywords
- Acellular dermal matrix, ADM, SurgiMend, Breast reconstruction, Immediate breast reconstruction, Autologous reconstruction, Biological mesh
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reconstruction - implant and an ADM (SurgiMend)Procedure or surgery
Also called SurgiMend
Skin or nipple sparing mastectomy and immediate breast reconstruction with implants and SurgiMend
Breast reconstruction- autologous tissueProcedure or surgery
Skin or nipple sparing mastectomy and immediate breast reconstruction with autologous tissue
Breast reconstruction- implant + dermal sling/LD flapProcedure or surgery
Skin or nipple sparing mastectomy and immediate breast reconstruction using an implant and a dermal sling or a latissimus dorsi flap
| Study group | Role | What they receive |
|---|---|---|
| Implant and Surgimend | Experimental | Breast reconstruction surgery with an implant and an ADM (Surgimend) Receives: Procedure: Breast reconstruction - implant and an ADM (SurgiMend) |
| Autologous tissue | Active comparator | Breast reconstruction surgery with autologous tissue Receives: Procedure: Breast reconstruction- autologous tissue |
| Implant + dermal sling/LD flap | Active comparator | Breast reconstruction surgery using a dermal sling or a latissimus dorsi (LD)flap Receives: Procedure: Breast reconstruction- implant + dermal sling/LD flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
Measured: 30 days
Number of patients with adverse events
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
Measured: 3 months
Number of patients with adverse events
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
Measured: 12 months
Secondary outcomes (3)
Aesthetic outcome measured by Photographic assessment
Photographic assessment
Measured: 12 months
BREAST-Q questionnaire score
Patient-reported outcome measures using the BREASTQ questionnaire
Measured: 30 days
BREAST-Q questionnaire score
Patient-reported outcome measures using the BREASTQ questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Integra LifeSciences Corporation
- Responsible party
- Sponsor
- Investigators
- Michael Douek, MD FRCS, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557906
- Sponsor's protocol ID
- 153962
- Acronym
- POBRAD-M
- Status last verified
- Mar 2018
- First submitted
- 28 Jul 2015
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-centre, Observational Trial Evaluating Outcomes of Immediate Breast Reconstruction Using an Implant and Acellular Dermal Matrix (SurgiMend) or Autologous Tissue
- ClinicalTrials.gov ID
- NCT02557906
- Acronym / sponsor ID
- POBRAD-M / 153962
- Conditions
- Breast Neoplasms, Breast Diseases
- Keywords
- Acellular dermal matrix, ADM, SurgiMend, Breast reconstruction, Immediate breast reconstruction, Autologous reconstruction, Biological mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 209 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Integra LifeSciences Corporation
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2020 (estimated)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some women with breast cancer have their whole breast removed as part of their treatment (mastectomy). Of these women, around 31% have more surgery to create a new breast.There are two main ways to create a new breast(i)using tissue from elsewhere on the body ("autologous" reconstruction )or (ii)using a silicone implant.
In recent years, it has been reported that by using a material called an "acellular dermal matrix" (ADM) the results of breast reconstruction surgery using an implant can be improved. ADMs are materials which originally come from animal or human skin. They act like a sling, supporting the lower part of an implant beneath the skin.
Although ADMs have been approved for used in breast reconstruction and are safe, there is very little high quality evidence to back up their reported benefits, and some studies have suggested their use may in fact increase complications.
The main purpose of this study is to find out what the actual risks and benefits of using an ADM in breast reconstruction surgery are. The investigators will follow the progress of women who have an implant based reconstruction to observe if participants develop problems; what those problems are and how participants feel about the results of their surgery. The investigators also follow the progress of women who undergo autologous reconstruction or alternative reconstructive techniques using an implant for the same reasons.
Detailed description
Despite the widespread adoption of acellular dermal matrices (ADMs) in breast reconstruction, there is limited prospective or high quality evidence on the outcomes of their use. The majority of studies on ADM are poor quality retrospective cohort studies with ill-defined, non-standardised outcome measures and heterogeneous patient populations. Recent systematic reviews have raised concerns of increased infection and seroma rates associated with ADM use which, if correct, may negate their reported advantages. Furthermore there is little high quality evidence to confirm the benefits associated with their use such as improved aesthetic outcomes.
The POBRAD-M is a prospective, multicentre trial which will evaluate the early and late outcomes of immediate breast reconstruction using either an implant and ADM, autologous tissue or an alternative implant-based technique. All participants must have been deemed suitable at the outset for implant based reconstruction with an ADM irrespective of their final procedure choice. All participants will be followed up at 30 days, 3 months and 12 months to record the incidence of complications (to include implant loss, infection, seroma, haematoma and skin necrosis). Additionally Patient Reported Outcomes measures using the BREAST-Q questionnaire will be determined at 30 days and 12 months, and aesthetic outcome will be determined by panel assessment of post-operative photographs at 12 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Implant and Surgimend | Experimental | Procedure: Breast reconstruction - implant and an ADM (SurgiMend)Breast reconstruction surgery with an implant and an ADM (Surgimend) |
| Autologous tissue | Active comparator | Procedure: Breast reconstruction- autologous tissueBreast reconstruction surgery with autologous tissue |
| Implant + dermal sling/LD flap | Active comparator | Procedure: Breast reconstruction- implant + dermal sling/LD flapBreast reconstruction surgery using a dermal sling or a latissimus dorsi (LD)flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent given
- Unilateral or bilateral mastectomy (therapeutic, contra lateral or prophylactic)
- Immediate reconstruction;
- Suitable for immediate implant reconstruction with ADM
Key exclusion criteria (3 listed)
- Patients unable to provide informed consent to participate in trial
- Patients unavailable for follow-up
- Not eligible for immediate breast reconstruction using an ADM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast reconstruction - implant and an ADM (SurgiMend)Also: SurgiMendSkin or nipple sparing mastectomy and immediate breast reconstruction with implants and SurgiMend | Procedure or surgery | Implant and Surgimend |
| Breast reconstruction- autologous tissueSkin or nipple sparing mastectomy and immediate breast reconstruction with autologous tissue | Procedure or surgery | Autologous tissue |
| Breast reconstruction- implant + dermal sling/LD flapSkin or nipple sparing mastectomy and immediate breast reconstruction using an implant and a dermal sling or a latissimus dorsi flap | Procedure or surgery | Implant + dermal sling/LD flap |
Primary outcome
Number of patients with adverse events
Time frame: 30 days
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
Number of patients with adverse events
Time frame: 3 months
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
Number of patients with adverse events
Time frame: 12 months
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
3 secondary outcomes
Aesthetic outcome measured by Photographic assessment
Time frame: 12 months
BREAST-Q questionnaire score
Time frame: 30 days
BREAST-Q questionnaire score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Douek, MD FRCS principal investigator
King's College London
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast reconstruction - implant and an ADM (SurgiMend), Breast reconstruction- autologous tissue and Breast reconstruction- implant + dermal sling/LD flap in people with Breast Neoplasms and Breast Diseases, run by King's College London at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.