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Secondary Breast Reconstruction With a Flap of Skin From the Back

NCT02169011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-08-14

No results posted yet for this study

Summary

The purpose of this study is to examine the different outcomes of breast reconstruction in women who are treated for breast cancer with mastectomy and subsequently have delayed breast reconstruction by one of two different surgical techniques both of which are based on the use of a tissue flap from the patient's back. These techniques are either a latissimus dorsi flap (LD-flap) or a thoracodorsal artery perforator flap (TAP-flap)

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

Latissimus Dorsi Flap Reconstruction

Delayed, unilateral breast reconstruction with the LD-flap. The reconstruction will be performed in a standard fashion as specified in the protocol. Implants should be used when required to gain sufficient volume of the breast.

PROCEDURE

TAP Flap Reconstruction

Delayed, unilateral breast reconstruction with the TAP-flap. The reconstruction will be performed as specified in the protocol and when implants are required to gain sufficient volume they should be combined with an acellular dermal matrix.

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Region of Southern Denmark

    collaborator OTHER

  • Sygehus Lillebaelt

    collaborator OTHER

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Jørn B Thomsen, MD, PhD · Center Hospital Lillebaelt, Institute of Regional Health Research, University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-03-31
Completion
2019-03-31

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 NCT02169011 on ClinicalTrials.gov