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Direct to Implant Breast Reconstruction Based Pre- or Retropectoral

NCT03143335 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-08-29

No results posted yet for this study

Summary

The purpose of this study is to examine different outcomes of breast reconstruction in women who are treated for breast cancer with skin sparing mastectomy and subsequently a primary implant based reconstruction by one of two different techniques with either a pre- or retropectoral placement of the implant.

The main objective of the study is to establish whether one of these techniques may result in a superior outcome and thus should be recommended as first choice treatment rather than the other.

Conditions

  • Breast Reconstruction

Interventions

PROCEDURE

Retropectoral immediate breast reconstruction

Immediate reconstruction with the implant placed in a standard fashion, i.e. retropectoral in combination with an acellular dermal matrix.

PROCEDURE

Prepectoral immediate breast reconstruction

Immediate breast reconstruction with the implant placed prepectoral supported by acellular dermal matrix alone.

Sponsors & Collaborators

  • Sygehus Lillebaelt

    collaborator OTHER

  • Sykehuset Telemark

    collaborator OTHER_GOV

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jørn Bo JB Thomsen, MD, PhD · Center Hospital Vejle, Institute of Regional Health Research, University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-04-01
Completion
2020-05-01

Countries

  • Denmark
  • Norway

Study Locations

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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 NCT03143335 on ClinicalTrials.gov