Regenerative Medicine Approach to Nasal Reconstruction

Regenerative Medicine Clinical Trial

Official title:

Regenerative Medicine Approach to Nasal Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273060
• Other study ID #: 21-004941
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Surgical Procedures
• Regenerative Medicine

Intervention

Procedure:
• 3D Nasal Reconstruction Planning
3D molds or models to use in the reconstruction of nasal cartilage

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viable nasal reconstruction	Total number of subjects to have successful nasal reconstruction with transfer of viable tissue to reconstruct nasal defect	6 months
Secondary	Nasal breathing	Total number of subjects to have ability to move air through the nose for purposes of breathing	6 months