Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

Not Applicable

Completed

• Conditions: Rhinoplasty

• 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

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