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Completed

NCT Number: NCT05566808

Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

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).

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Key information

Conditions

Rhinoplasty

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Costal Cartilage Graft

Other

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

Costal Cartilage Allograft.

Other

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

Primary outcomes

  1. Patient Outcome Assessment

    Time frame: Preoperative

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

  2. Patient Outcome Assessment

    Time frame: 3 months post-operative

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

  3. Patient Outcome Assessment

    Time frame: 6 months post-operative

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

  4. Patient Outcome Assessment

    Time frame: 12 months

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

Secondary outcomes

  1. Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc.

    Time frame: 12 months

  2. Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures.

    Time frame: 12 months

Other outcomes

  1. Safety: occurrence of adverse events (AEs)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Musculoskeletal Transplant Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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