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Breast Reconstruction Outcomes With and Without StratticE (BROWSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Brief Summary:

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

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Implant reconstruction with Strattice
Women having immediate breast reconstruction with partial or total Strattice cover
Procedure: Strattice
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



Primary Outcome Measures :
  1. Percentage of patients planned loss of implant within 12 months of immediate reconstruction [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quality of Life questionnaire [ Time Frame: 8 years ]
  2. In-patient treatment costs [ Time Frame: 8 years ]
  3. Ipsilateral Revision rates [ Time Frame: 1-8 years ]
  4. Cosmesis [ Time Frame: 1-8 years ]
    Cosmesis domains of Breast-Q quality of life questionnaire and likert 1-5 scale

  5. Breast Reconstruction softness [ Time Frame: 1-8 years ]
    Using tonometric measurement of breast softness

  6. Regional pain [ Time Frame: 1-8 years ]
    Using pain domain of Breast-Q Quality of Life questionnaire

  7. loco-regional cancer recurrence [ Time Frame: 1-8 years ]
  8. Morbidity [ Time Frame: 1-8 years ]

Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Patients age 18 years or older at the time of surgery.
  • Patients who have undergone immediate Implant-based breast reconstruction with or without Strattice™ with a minimum follow-up of six months.
  • Patients capable of providing informed consent.
Criteria

Inclusion Criteria:

  • Patients age 18 years or older at the time of surgery.
  • Patients who have undergone immediate Implant-based breast reconstruction with or without Strattice™ with a minimum follow-up of six months.
  • Patients capable of providing informed consent.

Exclusion Criteria:

  • Patients who have had an immediate implant-based breast reconstruction with an alternative brand of matrix/mesh to Strattice™.
  • Patients who have had a flap based-reconstruction with implant.
  • Delayed reconstructions.

Information from the National Library of Medicine

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


Contacts
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Contact: sarah sahin sarah.sahin@uhsm.nhs.uk

Sponsors and Collaborators
Manchester University NHS Foundation Trust
LifeCell
Investigators
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Principal Investigator: Richard Johnson University Hospital of South Manchester

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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02608593    
Other Study ID Numbers: BROWSE
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: October 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases