Breast Reconstruction Outcomes With and Without StratticE (BROWSE)
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|ClinicalTrials.gov Identifier: NCT02608593|
Recruitment Status : Unknown
Verified October 2015 by Manchester University NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : November 18, 2015
Last Update Posted : May 11, 2016
Approximately 4,000 women undergo a mastectomy for breast cancer each year in the UK and around 1,500 will have an immediate breast reconstruction. Approximately half of these ladies will have an implant-based breast reconstruction, of which many have an "implant-assisted" breast reconstruction with an Acellular Dermal Matrix.
Strattice™ is an Acellular Dermal Matrix (a pig skin product) made by Acelity. It is used to cover and disguise the lower part of the breast implant. Acellular Dermal Matrices have only been widely used for the last eight years and long-term outcomes for women who have had this form of reconstruction are lacking. Despite this, it is one of the most commonly offered methods of breast reconstruction in the UK for both ladies with a diagnosis of breast cancer and in the risk-reduction setting.
The objective of this study is to assess long-term outcomes of Strattice™-based breast reconstructions in multiple Breast Surgery Centres across the UK. This will be a case-control study comparing women who have had an immediate implant-based breast reconstruction with Strattice™ (case) or without (control). This will be achieved by review and analysis of retrospective data from patients who have undergone immediate breast reconstruction using implants with or without Strattice™ following either a diagnosis breast cancer or for risk-reduction. In addition there will be a prospective clinical assessment of the reconstruction outcomes. Outcomes assessed will include complications, surgical re-interventions and aesthetic results. These will be related to co-morbid conditions and other risk factors. Data will also be collected on unplanned interventions associated with a cost, if available.
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Procedure: Strattice|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Observational Model:||Case Control|
|Official Title:||Breast Reconstruction Outcomes With and Without StratticE (BROWSE)|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Implant reconstruction with Strattice
Women having immediate breast reconstruction with partial or total Strattice cover
Implant based reconstruction with strattice cover of part or all of implant
Implant reconstruction without Strattice
Women having immediate implant based breast reconstruction where no Strattice has been used
- Percentage of patients planned loss of implant within 12 months of immediate reconstruction [ Time Frame: 12 months ]
- Quality of Life questionnaire [ Time Frame: 8 years ]
- In-patient treatment costs [ Time Frame: 8 years ]
- Ipsilateral Revision rates [ Time Frame: 1-8 years ]
- Cosmesis [ Time Frame: 1-8 years ]Cosmesis domains of Breast-Q quality of life questionnaire and likert 1-5 scale
- Breast Reconstruction softness [ Time Frame: 1-8 years ]Using tonometric measurement of breast softness
- Regional pain [ Time Frame: 1-8 years ]Using pain domain of Breast-Q Quality of Life questionnaire
- loco-regional cancer recurrence [ Time Frame: 1-8 years ]
- Morbidity [ Time Frame: 1-8 years ]
- Effect of Radiotherapy [ Time Frame: 1-8 years ]Patients will be recorded as to whether they have or have not received radiotherapy. Effect of radiotherapy on the primary and secondary outcome measures will be compared between and within groups
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): NCT02608593
|Contact: sarah email@example.com|
|Principal Investigator:||Richard Johnson||University Hospital of South Manchester|