Diced Cartilage in Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NovoX®Cup as Primary Dressing After Breast Reduction

NCT06420323

Wound Healing Disorder Post-Surgical Complication Mammaplasty

RECRUITING

Silicone Taping for the Improvement of Abdominal Donor Site Scars

NCT04506255

Hypertrophic Scar Scar

RECRUITING NA

Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction

NCT05028816

Surgical Incision

COMPLETED NA

Protecting Autologous Free Flaps From Ischemia/Reperfusion Damage With Cold Storage.

NCT06523920

Ischemia Reperfusion Injury

NOT_YET_RECRUITING NA

Impact of Iron Stores on Wound Healing in Plastic Surgery

NCT04276168

Healing Wound Iron-deficiency Surgical Wound

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mammaplasty Microsurgery Rip Reconstruction Cartilage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

diced cartilage

Intervention Type 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.

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes