CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Latissimus Dorsi Flap Reconstruction +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02169011
NCT02169011N/ACompleted
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Delayed Breast Reconstruction With Skin Flap From the Back

Vejle Hospital·interventional·Posted Jun 20, 2014·Updated Aug 14, 2019

In Brief

A clinical study evaluating Latissimus Dorsi Flap Reconstruction and TAP Flap Reconstruction for Breast Reconstruction. Completed, enrolled 50 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Reconstruction
CountriesDenmark, Norway
CollaboratorsUniversity of Southern Denmark, Region of Southern Denmark, Sygehus Lillebaelt

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 20, 2014
Enrollment StartSep 1, 2013
Primary CompletionMar 1, 2018
Study CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 12.0 years ago

Interventions

Latissimus Dorsi Flap Reconstructionprocedure

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.

TAP Flap Reconstructionprocedure

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.