Diced Cartilage in Breast Reconstruction

Completed

• Conditions: Rip Reconstruction Cartilage; Mammaplasty; Microsurgery

• Registration Number: NCT06504173
• Lead Sponsor: ISAR Klinikum

Brief 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).

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-06-30
• Status Verified: 2024-07
• Study Completion: 2024-07-01
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 173

Inclusion Criteria

• Autologous free flap breast reconstruction using the internal mammary vessels as recipient vessels from October 2021 to June 2023
• MRI subcohort: Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively

Exclusion Criteria

• Autologous free flap breast reconstruction using a perforator of the internal mammary vessels as recipient vessels from October 2021 to June 2023
• Autologous free flap breast reconstruction using the thoracodorsal vessels as recipient vessels from October 2021 to June 2023

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area	October 2021 to June 2023	the sinking depth of epicostal soft tissue into the space of rib segment resection on axial planes in Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Visual contour deficit of the recipient vessels area	October 2021 to June 2023	Postoperative photographic images were examined by two investigators (blinded to group assignments) for IMVES-associated deformities using standardized photographic images of the reconstructed breasts at the 6-month follow-up.

Trial Locations

Locations (2)

ISAR Klinikum - Department Plastic Surgery; 🇩🇪 Munich, Bavaria, Germany

ISAR Klinikum; 🇩🇪 Munich, Bavaria, Germany