Evaluating Outcomes of Immediate Breast Reconstruction (POBRAD-M)
POBRAD-M
Prospective, Multi-centre, Observational Trial Evaluating Outcomes of Immediate Breast Reconstruction Using an Implant and Acellular Dermal Matrix (SurgiMend) or Autologous Tissue
1 other identifier
interventional
209
1 country
6
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedMarch 13, 2018
March 1, 2018
1.5 years
July 28, 2015
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of patients with adverse events
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
30 days
Number of patients with adverse events
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
3 months
Number of patients with adverse events
Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts
12 months
Secondary Outcomes (3)
Aesthetic outcome measured by Photographic assessment
12 months
BREAST-Q questionnaire score
30 days
BREAST-Q questionnaire score
12 months
Study Arms (3)
Implant and Surgimend
EXPERIMENTALBreast reconstruction surgery with an implant and an ADM (Surgimend)
Autologous tissue
ACTIVE COMPARATORBreast reconstruction surgery with autologous tissue
Implant + dermal sling/LD flap
ACTIVE COMPARATORBreast reconstruction surgery using a dermal sling or a latissimus dorsi (LD)flap
Interventions
Skin or nipple sparing mastectomy and immediate breast reconstruction with implants and SurgiMend
Skin or nipple sparing mastectomy and immediate breast reconstruction with autologous tissue
Skin or nipple sparing mastectomy and immediate breast reconstruction using an implant and a dermal sling or a latissimus dorsi flap
Eligibility Criteria
You may qualify if:
- Informed consent given
- Unilateral or bilateral mastectomy (therapeutic, contra lateral or prophylactic)
- Immediate reconstruction;
- Suitable for immediate implant reconstruction with ADM
You may not qualify if:
- Patients unable to provide informed consent to participate in trial
- Patients unavailable for follow-up
- Not eligible for immediate breast reconstruction using an ADM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- Guy's and St Thomas' NHS Foundation Trustcollaborator
- Integra LifeSciences Corporationcollaborator
Study Sites (6)
Royal Hampshire County Hospital
Winchester, Hampshire, United Kingdom
Frimley Park Hospitals NHS Foundation Trust
Frimley, United Kingdom
Leeds Teaching Hospitals
Leeds, United Kingdom
Department of Research Oncology, King's College London
London, SE1 9RT, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Douek, MD FRCS
King's College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2015
First Posted
September 23, 2015
Study Start
July 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2020
Last Updated
March 13, 2018
Record last verified: 2018-03