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OpenTrials
Completed

NCT Number: NCT06504173

Diced Cartilage in 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.

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Key information

Conditions

Mammaplasty Microsurgery Rip Reconstruction Cartilage

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

ISAR Klinikum, Munich, Bavaria, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diced cartilage

Procedure

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.

Primary outcomes

  1. Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area

    Time frame: 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 outcomes

  1. Visual contour deficit of the recipient vessels area

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ISAR Klinikum

Other

Collaborators

  • Breast Imaging Division, Radiologie Augsburg Friedberg / Breast Center Augsburg, Augsburg, Germany

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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