Secondary Breast Reconstruction With a Flap of Skin From the Back

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02169011
• Date of registration: 18/06/2014
• Prospective Registration: No
• Primary sponsor: Vejle Hospital
• Public title: Secondary Breast Reconstruction With a Flap of Skin From the Back
• Scientific title: Delayed Breast Reconstruction With Skin Flap From the Back
• Date of first enrolment: September 2013
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02169011
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark, Norway

Contacts

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

Key inclusion & exclusion criteria

To avoid bias relating to the possible effect on the outcome measures caused by other
surgical procedures such as mastectomy and axillary surgery performed simultaneously with
the reconstruction only delayed procedures will be studied, as these are also most commonly
the cases where autologous tissue transfer is required.

Patients that should thus be assessed for eligibility will include all women referred to
the participating centres for unilateral, delayed breast reconstruction in the inclusion
period. The criteria for participation are as follows:

Inclusion criteria:

1) Women over 18 years of age who are referred in the period between 1st of September 2013
and 30st of August 2015 for the purpose of unilateral, delayed breast reconstruction, and
who are found best suited for reconstruction with a pedicled tissue flap from the back.

Exclusion criteria

1. Patients found better suited for reconstruction by another method i.e. abdominal or
free flap-reconstruction or expander/implant-based reconstruction.

2. Patients with severe dementia that makes it impossible to collect data or obtain
informed consent

3. Non-Danish speaking patients from whom informed consent cannot be obtained by
interpreter

4. Patients where a suited perforator of the Thoracodorsal artery cannot be identified by
colour Doppler ultrasonography.

All women referred for delayed breast reconstruction in the inclusion period will be
assessed for eligibility and those meeting the criteria of the study population will be
invited to participate in the study. The assessment will be conducted at the preliminary
examination in the outpatient clinic by one of the centres consultants assigned to the
trial.

Invited patients will receive both oral and written participant information after which a
period of minimum 14 days is required before the patient can be enrolled in the trial in
accordance with the The Danish Health Act.

Patients considering participation will be invited for a second consultation where written
informed consent will be obtained from all who accept the invitation. Randomization will be
performed immediately afterwards allocating the patient to reconstruction by either the
LD-flap or the TAP-flap. Patients who do not which to be enrolled in the trial will be
offered reconstruction with the LD-flap as this must be considered standard of care.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Reconstruction

Intervention(s)

Procedure: Latissimus Dorsi Flap Reconstruction

Procedure: TAP Flap Reconstruction

Primary Outcome(s)

Shoulder Function [Time Frame: 1 year]

Secondary Outcome(s)

Rehabilitation [Time Frame: 1 year]

Patient Reported Discomfort [Time Frame: 1 year]

Secondary ID(s)

S-20120207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sygehus Lillebaelt

Region of Southern Denmark

University of Southern Denmark