Breast Reconstruction Outcomes With and Without StratticE

NCT02608593 | Completed DMC

• 1 other identifier: BROWSE
• Study Type: observational
• Target: 121
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (8)

• 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

Other Outcomes (1)

• Effect of Radiotherapy

  1-8 years

Study Arms (2)

Implant reconstruction with Strattice

Women having immediate breast reconstruction with partial or total Strattice cover

Procedure: Strattice

Implant reconstruction without Strattice

Women having immediate implant based breast reconstruction where no Strattice has been used

Interventions

Strattice PROCEDURE

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

Implant reconstruction with Strattice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• LifeCell: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

strattice

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard Johnson

  University Hospital of South Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 18, 2015
• Study Start: August 19, 2016
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: May 22, 2020

Record last verified: 2020-05