Regenerative Medicine Approach to Nasal Reconstruction

Mayo Clinic7 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasal Surgical Procedures Regenerative Medicine

Interventions

3D Nasal Reconstruction PlanningPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Viable nasal reconstruction

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

Time frame: 6 months

Secondary Outcomes

Nasal breathing

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

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.