Clinical trial NCT05273060: Regenerative Medicine Approach to Nasal Reconstruction
Official title: Regenerative Medicine Approach to Nasal Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasal Surgical Procedures
Regenerative Medicine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Viable nasal reconstruction
timeFrame: 6 months
Secondary outcomes:
measure: Nasal breathing
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Brittany Howard, MD
role: PRINCIPAL_INVESTIGATOR
References: