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Clinical Trials/NCT04209010
NCT04209010CompletedNot Applicable

Comparison of One-stage Direct-to-implant With Acellular Dermal Matrix and Two-stage Implant-based Breast Reconstruction: A Cohort Study

Aarhus University Hospital0 sites44 target enrollmentStarted: December 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
44
Primary Endpoint
Postoperative complications
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer
  • •Mastectomy weight ≤ 600 g
  • •Patient older than 18 years
  • •Ability to complete the study questionnaire
  • •Only for the two-stage group no later than 2 years and 4 months from breast reconstruction

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Postoperative complications

Time Frame: 3 months

Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.

Secondary Outcomes

  • Patient assessed satisfaction with aesthetic result(2 years)
  • Investigator assessed satisfaction with aesthetic result(2 years)
  • Patient reported outcome measures(2 years)
  • Cost(2 years)

Investigators

Sponsor
Aarhus University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mette Eline Brunbjerg, MD

MD, PhD student, Principal Investigator

Aarhus University Hospital

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