NCT05566808

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

3.6 years

First QC Date

September 28, 2022

Last Update Submit

September 30, 2022

Conditions

Rhinoplasty

Outcome Measures

Primary Outcomes (4)

  • Patient Outcome Assessment

    Subjective assessment using the Face-Q checklists and scoring for preoperative assessment.

    Preoperative

  • Patient Outcome Assessment

    Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.

    3 months post-operative

  • Patient Outcome Assessment

    Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.

    6 months post-operative

  • Patient Outcome Assessment

    Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.

    12 months

Secondary Outcomes (2)

  • 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

Other Outcomes (1)

  • Safety: occurrence of adverse events (AEs)

    12 months

Study Arms (2)

Autologous Costal Cartilage Graft

OTHER

Patients undergoing rhinoplasty will receive autologous rib graft.

Other: Autologous Costal Cartilage Graft

Costal Cartilage Allograft

OTHER

Patients undergoing rhinoplasty will receive costal cartilage allograft.

Other: Costal Cartilage Allograft.

Interventions

Autologous Costal Cartilage GraftOTHER

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

Autologous Costal Cartilage Graft
Costal Cartilage Allograft.OTHER

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

Costal Cartilage Allograft

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 4, 2022

Study Start

March 1, 2017

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 4, 2022

Record last verified: 2022-09

Locations

US(1)