Evaluating Outcomes of Immediate Breast Reconstruction (POBRAD-M) (POBRAD-M)
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|ClinicalTrials.gov Identifier: NCT02557906|
Recruitment Status : Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : March 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Breast Diseases||Procedure: Breast reconstruction - implant and an ADM (SurgiMend) Procedure: Breast reconstruction- autologous tissue Procedure: Breast reconstruction- implant + dermal sling/LD flap||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||209 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multi-centre, Observational Trial Evaluating Outcomes of Immediate Breast Reconstruction Using an Implant and Acellular Dermal Matrix (SurgiMend) or Autologous Tissue|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2020|
Experimental: Implant and Surgimend
Breast reconstruction surgery with an implant and an ADM (Surgimend)
Procedure: Breast reconstruction - implant and an ADM (SurgiMend)
Skin or nipple sparing mastectomy and immediate breast reconstruction with implants and SurgiMend
Other Name: SurgiMend
Active Comparator: Autologous tissue
Breast reconstruction surgery with autologous tissue
Procedure: Breast reconstruction- autologous tissue
Skin or nipple sparing mastectomy and immediate breast reconstruction with autologous tissue
Active Comparator: Implant + dermal sling/LD flap
Breast reconstruction surgery using a dermal sling or a latissimus dorsi (LD)flap
Procedure: Breast reconstruction- implant + dermal sling/LD flap
Skin or nipple sparing mastectomy and immediate breast reconstruction using an implant and a dermal sling or a latissimus dorsi flap
- 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
- Aesthetic outcome measured by Photographic assessment [ Time Frame: 12 months ]Photographic assessment
- BREAST-Q questionnaire score [ Time Frame: 30 days ]Patient-reported outcome measures using the BREASTQ questionnaire
- BREAST-Q questionnaire score [ Time Frame: 12 months ]Patient-reported outcome measures using the BREASTQ questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557906
|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, United Kingdom, SE1 9RT|
|Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, United Kingdom|
|Royal Cornwall Hospital|
|Truro, United Kingdom|
|Principal Investigator:||Michael Douek, MD FRCS||King's College London|