대한두개안면성형외과학회지 (Archives of Craniofacial Surgery)

  • 제23권4호
  • /
  • Pages.152-162
  • /
  • 2022
  • /
  • 2287-1152(pISSN)
  • /
  • 2287-5603(eISSN)
대한두개안면성형외과학회 (Korean Cleft Palate-Craniofacial Association)
권호 표지
DOI QR코드

DOI QR Code

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)
  • 투고 : 2022.05.24
  • 심사 : 2022.06.24
  • 발행 : 2022.08.20
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

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.

키워드

과제정보

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

참고문헌

  1. Koh IS, Sun H. A practical approach to nasal reconstruction in Asian patients. Arch Craniofac Surg 2021;22:268-75. https://doi.org/10.7181/acfs.2021.00465
  2. Jang YJ, Alfanta EM. Rhinoplasty in the Asian nose. Facial Plast Surg Clin North Am 2014;22:357-77. https://doi.org/10.1016/j.fsc.2014.04.001
  3. Hwang NH, Han SK, Dhong ES. Adaptive planning and overcoming pitfalls in Asian rhinoplasty. Arch Aesthetic Plast Surg 2014;20:8-14. https://doi.org/10.14730/aaps.2014.20.1.8
  4. Romo T 3rd, Pearson JM. Nasal implants. Facial Plast Surg Clin North Am 2008;16:123-32. https://doi.org/10.1016/j.fsc.2007.09.004
  5. Parker Porter J. Grafts in rhinoplasty: alloplastic vs. autogenous. Arch Otolaryngol Head Neck Surg 2000;126:558-61. https://doi.org/10.1001/archotol.126.4.558
  6. Yoon SH, Kim CS, Oh JW, Lee KC. Optimal harvest and efficient use of septal cartilage in rhinoplasty. Arch Craniofac Surg 2021;22:11-6. https://doi.org/10.7181/acfs.2020.00486
  7. Lee Y, Choi H. Reconstructive rhinoplasty with costal cartilage grafting: a case report of relapsing polychondritis. Arch Craniofac Surg 2019;20:341-4. https://doi.org/10.7181/acfs.2019.00437
  8. Kim JH, Song JW, Park SW, Oh WS, Lee JH. 10th rib cartilage: another option of the costal cartilage graft for rhinoplasty. Arch Aesthetic Plast Surg 2015;21:47-53. https://doi.org/10.14730/aaps.2015.21.2.47
  9. Rohrich RJ, Dayan E, Durand PD, Brito I, Gronet E. Warping characteristics of rib allograft cartilage. Plast Reconstr Surg 2020;146:37e-42e. https://doi.org/10.1097/PRS.0000000000006896
  10. Balaji SM. Costal cartilage nasal augmentation rhinoplasty: study on warping. Ann Maxillofac Surg 2013;3:20-4. https://doi.org/10.4103/2231-0746.110070
  11. Kim IS. Augmentation rhinoplasty using silicone implants. Facial Plast Surg Clin North Am 2018;26:285-93. https://doi.org/10.1016/j.fsc.2018.03.003
  12. Kangesu L, Goodacre TE, Stanley PR. Survival of irradiated glutaraldehyde preserved bovine cartilage in nasal reconstruction: a retrospective study. Br J Plast Surg 1991;44:483-5. https://doi.org/10.1016/0007-1226(91)90002-2
  13. Lo S, Kenway B, Hosni A. Acellular porcine dermal collagen implant in saddle nose deformity. Plast Reconstr Surg 2011; 128:82e-84e. https://doi.org/10.1097/PRS.0b013e31821ef15f
  14. Das P, Singh YP, Joardar SN, Biswas BK, Bhattacharya R, Nandi SK, et al. Decellularized caprine conchal cartilage toward repair and regeneration of damaged cartilage. ACS Appl Bio Mater 2019;2:2037-49. https://doi.org/10.1021/acsabm.9b00078
  15. Velasquez N, Huang Z, Humphreys IM, Nayak JV. Inferior turbinate reconstruction using porcine small intestine submucosal xenograft demonstrates improved quality of life outcomes in patients with empty nose syndrome. Int Forum Allergy Rhinol 2015;5:1077-81. https://doi.org/10.1002/alr.21633
  16. Marianetti TM, Grussu F, Cervelli D, Gasparini G, Pelo S. Equine pericardium membrane to prevent dorsal irregularities in rhinoplasty. Ann Plast Surg 2014;73:128-30. https://doi.org/10.1097/sap.0b013e31827100fa
  17. Alsarraf R. Outcomes research in facial plastic surgery: a review and new directions. Aesthetic Plast Surg 2000;24:192-7. https://doi.org/10.1007/s002660010031
  18. Jeong JY, Ha Y, Kim S, Yang HJ, Oh SH. Availability and safety of osteotomy in esthetic rhinoplasty of East Asian patients. Ann Plast Surg 2018;81:141-5. https://doi.org/10.1097/SAP.0000000000001472
  19. Sena Esteves S, Goncalves Ferreira M, Carvalho Almeida J, Abrunhosa J, Almeida E Sousa C. Evaluation of aesthetic and functional outcomes in rhinoplasty surgery: a prospective study. Braz J Otorhinolaryngol 2017;83:552-7. https://doi.org/10.1016/j.bjorl.2016.06.010
  20. D'Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues: the encounters of academic consultants in statistics. Stat Med 2003;22:169-86. https://doi.org/10.1002/sim.1425
  21. Ortiz-Monasterio F, Olmedo A, Oscoy LO. The use of cartilage grafts in primary aesthetic rhinoplasty. Plast Reconstr Surg 1981;67:597-605. https://doi.org/10.1097/00006534-198105000-00003
  22. Kim TK, Jeong JY. Surgical anatomy for Asian rhinoplasty: part II. Arch Craniofac Surg 2020;21:143-55. https://doi.org/10.7181/acfs.2020.00234
  23. Gunter JP, Cochran CS, Marin VP. Dorsal augmentation with autogenous rib cartilage. Semin Plast Surg 2008;22:74-89. https://doi.org/10.1055/s-2008-1063567
  24. Gunter JP, Clark CP, Friedman RM. Internal stabilization of autogenous rib cartilage grafts in rhinoplasty: a barrier to cartilage warping. Plast Reconstr Surg 1997;100:161-9. https://doi.org/10.1097/00006534-199707000-00026
  25. Vila PM, Jeanpierre LM, Rizzi CJ, Yaeger LH, Chi JJ. Comparison of autologous vs homologous costal cartilage grafts in dorsal augmentation rhinoplasty: a systematic review and metaanalysis. JAMA Otolaryngol Head Neck Surg 2020;146:347-54. https://doi.org/10.1001/jamaoto.2019.4787
  26. Starr NC, Creel L, Harryman C, Gupta N. Cost utility analysis of costal cartilage autografts and human cadaveric allografts in rhinoplasty. Ann Otol Rhinol Laryngol 2022;131:1123-9. https://doi.org/10.1177/00034894211058115
  27. Ferrante B, Biessy R, Ducroz V, Gzaiel D, Leyder P. Correction of nose deviations using latero-septal grafts from irradiated bovine cartilage. Ann Chir Plast Esthet 1993;38:555-60.
  28. Demir CI, Yasar EK, Davun K, Gok A, Uzun C, Alagoz MS. Creation of experimental human nose model with lyophilized and decellularized bovine cartilage xenograft. J Craniofac Surg 2018;29:1097-100. https://doi.org/10.1097/scs.0000000000004546
  29. Lin S, He Y, Tao M, Wang A, Ao Q. Fabrication and evaluation of an optimized xenogenic decellularized costal cartilage graft: preclinical studies of a novel biocompatible prosthesis for rhinoplasty. Regen Biomater 2021;8:rbab052. https://doi.org/10.1093/rb/rbab052
  30. von Bomhard A, Elsaesser A, Riepl R, Pippich K, Faust J, Schwarz S, et al. Cartilage regeneration using decellularized cartilage matrix: long-term comparison of subcutaneous and intranasal placement in a rabbit model. J Craniomaxillofac Surg 2019;47:682-94. https://doi.org/10.1016/j.jcms.2019.01.010
  31. Bhattacharya R, Das P, Joardar SN, Biswas BK, Batabyal S, Das PK, et al. Novel decellularized animal conchal cartilage graft for application in human patient. J Tissue Eng Regen Med 2019;13:46-57. https://doi.org/10.1002/term.2767
  32. Benders KE, van Weeren PR, Badylak SF, Saris DB, Dhert WJ, Malda J. Extracellular matrix scaffolds for cartilage and bone regeneration. Trends Biotechnol 2013;31:169-76. https://doi.org/10.1016/j.tibtech.2012.12.004
  33. Stone KR, Walgenbach AW, Abrams JT, Nelson J, Gillett N, Galili U. Porcine and bovine cartilage transplants in cynomolgus monkey: I. A model for chronic xenograft rejection. Transplantation 1997;63:640-5. https://doi.org/10.1097/00007890-199703150-00005
  34. Schwarz S, Koerber L, Elsaesser AF, Goldberg-Bockhorn E, Seitz AM, Durselen L, et al. Decellularized cartilage matrix as a novel biomatrix for cartilage tissue-engineering applications. Tissue Eng Part A 2012;18:2195-209. https://doi.org/10.1089/ten.TEA.2011.0705
  35. Oungoulian SR, Hehir KE, Zhu K, Willis CE, Marinescu AG, Merali N, et al. Effect of glutaraldehyde fixation on the frictional response of immature bovine articular cartilage explants. J Biomech 2014;47:694-701. https://doi.org/10.1016/j.jbiomech.2013.11.043
  36. Wang JH, Jang YJ, Park SK, Lee BJ. Measurement of aesthetic proportions in the profile view of Koreans. Ann Plast Surg 2009;62:109-13. https://doi.org/10.1097/SAP.0b013e31817e2c87
  37. Zelken JA, Hong JP, Broyles JM, Hsiao YC. Preventing elevated radix deformity in Asian rhinoplasty with a chimeric dorsalglabellar construct. Aesthet Surg J 2016;36:287-96. https://doi.org/10.1093/asj/sjv218