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临床试验/NCT02608593
NCT02608593已完成不适用

Breast Reconstruction Outcomes With and Without StratticE (BROWSE)

Manchester University NHS Foundation Trust0 个研究点目标入组 121 人开始时间: 2016年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
121
主要终点
Percentage of patients planned loss of implant within 12 months of immediate reconstruction

研究概览

简要总结

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.

详细描述

Primary Outcome The primary outcome measure will be unexpected loss of the implant.

Secondary Outcomes

To investigate short and long-term outcomes with Strattice™ including:

  • Quality of Life
  • In-patient treatment costs
  • Ipsilateral Revision rates
  • Aesthetic outcome
  • Breast reconstruction softness (Tonometry)
  • Regional pain
  • Loco-regional recurrence
  • Effect of radiotherapy
  • Complications - (seroma drainage, skin necrosis/ wound breakdown)

Study Design

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Percentage of patients planned loss of implant within 12 months of immediate reconstruction

时间窗: 12 months

次要结局

  • Quality of Life questionnaire(8 years)
  • In-patient treatment costs(8 years)
  • Ipsilateral Revision rates(1-8 years)
  • Cosmesis(1-8 years)
  • Breast Reconstruction softness(1-8 years)
  • Regional pain(1-8 years)
  • loco-regional cancer recurrence(1-8 years)
  • Morbidity(1-8 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

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