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.

Study Overview

• Status: Recruiting
• Conditions: Regenerative Medicine; Nasal Surgical Procedures
• Intervention / Treatment: Procedure: 3D Nasal Reconstruction Planning

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
      • Contact: Brittany Howard, MD; Phone Number: 480-342-2928; Email: howard.brittany@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Nasal Reconstruction Planning; Subjects undergoing nasal reconstruction will have standard planning for procedure.
Experimental: 3D Nasal Reconstruction Planning; Subjects undergoing nasal reconstruction will have 3D planning utilized by the surgical team for the procedure.	Procedure: 3D Nasal Reconstruction Planning; 3D molds or models to use in the reconstruction of nasal cartilage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viable nasal reconstruction	Total number of subjects to have successful nasal reconstruction with transfer of viable tissue to reconstruct nasal defect	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal breathing	Total number of subjects to have ability to move air through the nose for purposes of breathing	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brittany Howard, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-004941

Drug and device information, study documents

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