Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

Rhinoplasty Clinical Trial

Official title:

Prospective Trial Evaluation the Long-term Outcomes Associated With the Use of MTF Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05566808
• Other study ID #: MTF Profile Study
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2022
• Source: Musculoskeletal Transplant Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, blinded, controlled trial, conducted in healthy adult subjects undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting of costal cartilage).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subject is scheduled to undergo a reconstructive or cosmetic surgical procedure to alter the appearance of the nose that is anticipated to require a cartilage graft.

• Subject is willing to sign an informed consent.

• Subject is a non-smoker or has stopped smoking at least 6-weeks prior to inclusion in the study.

• Subjects must agree to forgo any treatment, medical or non-medical, to the area treated in this study, for the duration of the 1-year post-treatment evaluation period, unless there is prior approval from the investigator.

Exclusion Criteria:

• Presence of significant endocrine, immunologic, dermatologic or psychiatric abnormalities that would render the subject an inappropriate candidate for the study.

• Presence of any malignancy not considered cured in the midface area specifically (no evidence of cancer recurrence in the previous five years).

• History of radiation to the area(s) to be treated in the study.

• Subjects taking chronic steroids (injected or oral) or other immune modulators.

• Subjects with a history of skin sensitivity (dermatitis) to either the suture materials or dressings to be utilized during the course of this study.

• Subjects with skin conditions that could result in poor healing or widened scars.

Related Conditions & MeSH terms

• Rhinoplasty

Intervention

Other:
• Autologous Costal Cartilage Graft
Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.
• Costal Cartilage Allograft.
Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: occurrence of adverse events (AEs)	Evaluation of the occurrence of adverse events (AEs) as documented by the treating physician during the course of treatment and follow-up visits and as reported by the subjects at each Assessment Visit.	12 months
Primary	Patient Outcome Assessment	Subjective assessment using the Face-Q checklists and scoring for preoperative assessment.	Preoperative
Primary	Patient Outcome Assessment	Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.	3 months post-operative
Primary	Patient Outcome Assessment	Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.	6 months post-operative
Primary	Patient Outcome Assessment	Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.	12 months
Secondary	Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc.		12 months
Secondary	Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures.		12 months