Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

NCT ID: NCT05566808

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-10-01

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).

Conditions

Rhinoplasty

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Autologous Costal Cartilage Graft

Patients undergoing rhinoplasty will receive autologous rib graft.

Group Type: OTHER

Autologous Costal Cartilage Graft

Intervention Type: OTHER

Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.

Costal Cartilage Allograft

Patients undergoing rhinoplasty will receive costal cartilage allograft.

Group Type: OTHER

Costal Cartilage Allograft.

Intervention Type: OTHER

Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.

Interventions

Autologous Costal Cartilage Graft

Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.

Intervention Type: OTHER

Costal Cartilage Allograft.

Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Musculoskeletal Transplant Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

MTF Profile Study

Identifier Type: -

Identifier Source: org_study_id