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OpenTrials
Completed

NCT Number: NCT05273060

Regenerative Medicine Approach to Nasal Reconstruction

The purpose of this study is to gather information on the safety and effectiveness and compare nasal reconstruction standard planning versus 3D preoperative scanning/printing/planning.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

About this study

Patients with nasal defects from cancer, trauma, prior surgery, or birth often require complex reconstruction. Current techniques involve hand sketched skin templates and/or hand carved cartilage grafts that are formed intraoperatively for nasal reconstruction. This process is time consuming, heavily depends on the surgeon's skill, cannot be standardized, and is difficult to visualize with patients preoperatively. To overcome these barriers and shift surgical paradigms, we will use a regenerative medicine approach to nasal reconstruction to create patient specific and individualized results. We will leverage regenerative medicine techniques of 3D surface mapping, 3D printing and modeling, and new tissue preparation techniques for skin template creation and sculpting of cartilage grafting. Clinically this will improve patient specific outcomes, increase reproducibility, reduce operative times, and allow for an individualized approach to nasal reconstruction. This will be achieved by (1) establishing ideal diced cartilage graft parameters in the laboratory setting for moldable cartilage graft formation. This knowledge will be applied to (2) create diced cartilage grafts for nasal dorsum and tip reconstruction from 3D printed nasal molds. For nasal skin reconstruction, (3) 3D facial scans of patients' preoperatively will be used to generate patient specific templates for skin reconstruction. Ultimately, (4) these regenerative medicine techniques of cartilage and skin reconstruction performed with 3D planning can be shared in an interactive format with patients preoperatively. This will allow patients to be involved in the surgical planning of their nasal reconstruction to increase their autonomy and the individualization of their surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males or female, age range is ≥ 18 to ≤ 100, based on historical surgical experience.
  • Patients undergoing nasal reconstruction.
  • Patients will be identified from the Facial Plastic Surgery clinic of the PI.

Exclusion criteria

  • Patients < 18 are excluded because these cases are in combination with providers from PCH and patients have shared/limited postoperative follow up as a result.

Treatment and study plan

3D Nasal Reconstruction Planning

Procedure

3D molds or models to use in the reconstruction of nasal cartilage

Primary outcomes

  1. Viable nasal reconstruction

    Time frame: 6 months

    Total number of subjects to have successful nasal reconstruction with transfer of viable tissue to reconstruct nasal defect

Secondary outcomes

  1. Nasal breathing

    Time frame: 6 months

    Total number of subjects to have ability to move air through the nose for purposes of breathing

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2022
Registry last updated
Jul 2, 2025

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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