Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

Not Applicable

Completed

• Conditions: Rhinoplasty
• Interventions: Other: Costal Cartilage Allograft.; Other: Autologous Costal Cartilage Graft

• Registration Number: NCT05566808
• Lead Sponsor: Musculoskeletal Transplant Foundation

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-30
• Last Update Submitted: 2022-09-30
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Costal Cartilage Allograft	Costal Cartilage Allograft.	Patients undergoing rhinoplasty will receive costal cartilage allograft.
Autologous Costal Cartilage Graft	Autologous Costal Cartilage Graft	Patients undergoing rhinoplasty will receive autologous rib graft.

Primary Outcome Measures

Name	Time	Method
Patient Outcome Assessment	12 months	Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.

Secondary Outcome Measures

Name	Time	Method
Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc.	12 months
Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures.	12 months

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States