Diced Cartilage in Breast Reconstruction

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

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.

Study Overview

• Status: Completed
• Conditions: Mammaplasty; Microsurgery; Rip Reconstruction Cartilage
• Intervention / Treatment: Procedure: diced cartilage

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 Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80331
      • ISAR Klinikum
    • Munich, Bavaria, Germany, 80331
      • ISAR Klinikum - Department Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women who received autologous free flap breast reconstruction using internal mammary vessels as recipient vessels.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
diced cartilage (DC); After removing a part of the rip cartilage and microsurgery, the exposed internal mammary vessels in autologous free flap breast reconstruction was restored with diced cartilage (DC) out of the removed rip cartialge.	Procedure: diced cartilage; In 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.
control; After removing a part of the rip cartilage and microsurgery, the exposed internal mammary vessels in autologous free flap breast reconstruction was NOT restored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area	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	October 2021 to June 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual contour deficit of the recipient vessels area	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.	October 2021 to June 2023

Collaborators and Investigators

• Sponsor: ISAR Klinikum
• Collaborators: Breast Imaging Division, Radiologie Augsburg Friedberg / Breast Center Augsburg, Augsburg, Germany
• Investigators: Study Director: Ulf Dornseifer, MD/PhD, Head of Department plastic and reconstructive surgery ISAR Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DIC-RIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No