Regenerative Medicine Approach to Nasal Reconstruction

Not Applicable

Recruiting

• Conditions: Nasal Surgical Procedures; Regenerative Medicine
• Interventions: Procedure: 3D Nasal Reconstruction Planning

• Registration Number: NCT05273060
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-10
• Study Start: 2022-05-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D Nasal Reconstruction Planning	3D Nasal Reconstruction Planning	Subjects undergoing nasal reconstruction will have 3D planning utilized by the surgical team for the procedure.

Primary Outcome Measures

Name	Time	Method
Viable nasal reconstruction	6 months	Total number of subjects to have successful nasal reconstruction with transfer of viable tissue to reconstruct nasal defect

Secondary Outcome Measures

Name	Time	Method
Nasal breathing	6 months	Total number of subjects to have ability to move air through the nose for purposes of breathing

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States