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Breast Reconstruction Outcomes With and Without StratticE

NCT02608593 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2020-05-22

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

PROCEDURE

Strattice

Implant based reconstruction with strattice cover of part or all of implant

Sponsors & Collaborators

  • LifeCell

    collaborator INDUSTRY

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Richard Johnson · University Hospital of South Manchester

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-19
Primary Completion
2019-10-31
Completion
2019-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02608593 on ClinicalTrials.gov