Archives of Craniofacial Surgery (대한두개안면성형외과학회지)

Korean Cleft Palate-Craniofacial Association (대한두개안면성형외과학회)
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Efficacy and safety of equine cartilage for rhinoplasty: a multicenter double-blind non-inferiority randomized confirmatory clinical trial

  • Chang, Yongjoon (Department of Plastic and Reconstructive Surgery, Kangdong Sacred Heart Hospital) ;
  • Yun, Hyunjong (Department of Plastic and Reconstructive Surgery, Kangdong Sacred Heart Hospital) ;
  • Choi, Jong Woo (Department of Plastic and Reconstructive Surgery, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Suh, Joong Min (Department of Plastic and Reconstructive Surgery, Kangdong Sacred Heart Hospital) ;
  • Jeong, Woo Shik (Department of Plastic and Reconstructive Surgery, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Park, Hojin (Department of Plastic and Reconstructive Surgery, Korea University Anam Hospital) ;
  • Kang, Min Kyu (Department of Plastic and Reconstructive Surgery, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Shin, Yongho (BIO Plastic Surgery Clinic) ;
  • Kim, Kuylhee (Department of Plastic and Reconstructive Surgery, Kangdong Sacred Heart Hospital) ;
  • Chung, Chul Hoon (Department of Plastic and Reconstructive Surgery, Kangdong Sacred Heart Hospital)
  • Received : 2022.05.24
  • Accepted : 2022.06.24
  • Published : 2022.08.20
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Abstract

Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

Keywords

Acknowledgement

This study was supported by L&C Bio (Suntechcity suite #605, #606, #607, 474; Seongnam, Korea) by sourcing nasal implants and funding study process.

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