ClinicalTrials.Veeva

Menu

Regenerative Medicine Approach to Nasal Reconstruction

Mayo Clinic logo

Mayo Clinic

Status

Completed

Conditions

Nasal Surgical Procedures
Regenerative Medicine

Treatments

Procedure: 3D Nasal Reconstruction Planning

Study type

Interventional

Funder types

Other

Identifiers

NCT05273060
21-004941

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7 participants in 2 patient groups

Standard of Care Nasal Reconstruction Planning
No Intervention group
Description:
Subjects undergoing nasal reconstruction will have standard planning for procedure.
3D Nasal Reconstruction Planning
Experimental group
Description:
Subjects undergoing nasal reconstruction will have 3D planning utilized by the surgical team for the procedure.
Treatment:
Procedure: 3D Nasal Reconstruction Planning

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems