Regenerative Medicine Approach to Nasal Reconstruction

NCT ID: NCT05273060

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2024-12-19

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.

Conditions

Nasal Surgical Procedures; Regenerative Medicine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care Nasal Reconstruction Planning

Subjects undergoing nasal reconstruction will have standard planning for procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

3D Nasal Reconstruction Planning

Subjects undergoing nasal reconstruction will have 3D planning utilized by the surgical team for the procedure.

Group Type: EXPERIMENTAL

3D Nasal Reconstruction Planning

Intervention Type: PROCEDURE

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

Interventions

3D Nasal Reconstruction Planning

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Brittany E. Howard

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brittany Howard, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Arizona

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

21-004941

Identifier Type: -

Identifier Source: org_study_id