Clinical Trials Directory

Trials / Completed

CompletedNCT06504173

Diced Cartilage in Breast Reconstruction

Use of Diced Cartilage for Management of Internal Mammary Vessel Exposure Sites in Autologous Breast Reconstruction

Status
Completed
Phase
Study type
Observational
Enrollment
173 (actual)
Sponsor
ISAR Klinikum · Academic / Other
Sex
Female
Age
18 Years – 99 Years
Healthy volunteers
Accepted

Summary

Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. This study evaluated the use of diced cartilage (DC) to counteract substance loss in the microvascular anastomosis area, and investigated safety and suitability of the procedure to avoid postoperative deformities.

Detailed description

This retrospective, single-center cohort study included all breast reconstructions in which DC was used from October 2021 to June 2023. Reconstructions using DC were subdivided based on previous exposure to breast radiotherapy (DC vs. DCR). The control group consisted of an equal number of consecutive reconstructions performed prior to the use of DC. The effect of DC on breast contour preservation was investigated using breast magnetic resonance imaging (MRI; \> 6 months post-op) and photographic documentation (6-month follow-up).

Conditions

Interventions

TypeNameDescription
PROCEDUREdiced cartilageIn reconstructions using DC management of IMVES, the surgical nurse processed the removed cartilage into DC using a dermatome blade. Cartilage pieces of approximately 0,5-1 mm were used. After microvascular anastomosis (coupler device for venous anastomosis; Synovis MCA, Birmingham AL, USA), all DC was placed back into the rib removal zone using a blunt dissector. The vessels were embedded and stabilized in cartilage paste according to the desired orientation.

Timeline

Start date
2024-01-01
Primary completion
2024-06-30
Completion
2024-07-01
First posted
2024-07-16
Last updated
2024-07-16

Locations

2 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT06504173. Inclusion in this directory is not an endorsement.