Multicenter Pilot Study to Assess a Biphasic Calcium Phosphate Implant for Functional and Aesthetic Septorhinoplasty
| Autor: | Aline Maillard, Antoine Bénard, Etienne Gontier, Marlène Durand, Philippe Boudard, Jean-Christophe Fricain, Sabrina Lacomme, Jean-Pierre Bessède, Ludovic de Gabory, Laurence Bordenave |
|---|---|
| Přispěvatelé: | Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Bioingénierie tissulaire (BIOTIS), Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Esthetics Dentistry Biocompatible Materials Pilot Projects Postoperative Complications Humans Medicine Prospective Studies Aged Nasal Septum Pain Measurement Wound Healing business.industry Biomaterial Prostheses and Implants Middle Aged Rhinoplasty Biphasic calcium phosphate 3. Good health Ambulatory Female Surgery [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie France Hydroxyapatites Implant business |
| Zdroj: | Facial Plastic Surgery & Aesthetic Medicine Facial Plastic Surgery & Aesthetic Medicine, 2021, 23 (5), pp.321-329. ⟨10.1089/fpsam.2020.0184⟩ |
| ISSN: | 2689-3614 |
| DOI: | 10.1089/fpsam.2020.0184⟩ |
| Popis: | Importance: A validated biomaterial would have several medical advantages in septorhinoplasties requiring a large-volume graft such as avoiding donor site morbidity, making ambulatory surgery possible, and reducing surgical costs. Objective: To assess the safety and efficacy of a ceramic to treat saddle and crooked noses. The main endpoint was the biocompatibility of the implant. The secondary endpoint was its functional and aesthetic efficacy. Design, Setting, and Participants: The nasal septum (NASEPT) study is a pilot multicenter noncomparative prospective phase IIa clinical trial. The biomaterial tested was a biphasic calcium phosphate implant composed of 75% hydroxyapatite and 25% beta tri calcium phosphate. This versatile material can be used to replace septal skeleton when it is absent or nonusable. We included 25 patients with a multifractured osseous and cartilaginous framework after several traumas or surgeries. The implant placement technique was identical to an extracorporeal septoplasty through the external approach. Main Outcomes and Measures: The primary endpoint was the occurrence of expected adverse and severe adverse events. The secondary endpoints were clinical functional and aesthetic results and histological microscopic modifications. Results: Any extrusion, infection, pain, and epistaxis were observed. All implants were placed in a sagittal, straight, and solid position without extralobular depression. Comparisons between pre- and postoperative symptoms showed that nasal comfort (p |
| Databáze: | OpenAIRE |
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