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Immediate Breast Reconstruction With Acellular Dermal Matrix

NCT04209010 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2020-01-03

No results posted yet for this study

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.

Conditions

  • Breast Cancer
  • Breast Carcinoma in Situ
  • Mammaplasty
  • Acellular Dermis

Interventions

PROCEDURE

one-stage technique

breast reconstruction in one stage using silicone implant and acellular dermal matrix.

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • The Korning foundation

    collaborator UNKNOWN

  • Foundation of the Kjaersgaard Family

    collaborator UNKNOWN

  • King Christian X foundation

    collaborator UNKNOWN

  • Foundation of architect Holger Hjortenberg

    collaborator UNKNOWN

  • LifeCell Corporation (Branchburg, NJ, USA)

    collaborator UNKNOWN

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Mette Eline Brunbjerg, MD · Aarhus University Hospital, Aarhus University, Denmark

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-01
Primary Completion
2016-03-17
Completion
2016-03-17

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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 NCT04209010 on ClinicalTrials.gov