Safety and Efficacy of Cosmetic Augmentation of the Nasal Tip and Nasal Dorsum With Expanded Polytetrafluoroethylene: A Randomized Clinical Trial

Importance Expanded polytetrafluoroethylene (ePTFE) is a widely used alloplast, but studies of augmentation of the nasal tip and nasal dorsum with ePTFE are lacking. Objective To investigate whether attaching the conchal cartilage as shield grafts at the distal end of the graft can prevent extrusion and whether the use of ePTFE in the nasal tip can achieve a stable aesthetic outcome. Design, Setting, and Participants A randomized clinical trial was performed from April 1, 2006, to October 31, 2008. Follow-up was completed in 2012 and 2017. The study was conducted at the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. One hundred fifty patients seeking rhinoplasty were recruited, and 129 were eligible for inclusion in the study. All the recruited patients were intent-to-treat populations who were randomized into 2 groups: an ePTFE-only group and an ePTFE with conchal cartilage group. Interventions Expanded PTFE was used for augmentation of the nasal tip and nasal dorsum in both groups. Conchal cartilage was placed above the distal end in the ePTFE with conchal cartilage group. Main Outcomes and Measures Preoperative and postoperative standard photographs were obtained. Postoperative satisfaction and complications were evaluated. Results Of the 129 patients (mean age [range], 28 years [21-45 years]; 6 male and 123 female) eligible for inclusion in this study, 76 (mean age [range], 31 years [22-45 years]; 4 male and 72 female) were available for follow-up (mean [range], 106.9 months [100-131 months]) through 2017, including 39 in the ePTFE-only group and 37 in the ePTFE with conchal cartilage group. Infection occurred in 2 patients (5%) in the ePTFE-only group vs 1 patient (3%) in the ePTFE with conchal cartilage group (infection rate [OR, 1.946; 95% CI, 0.169-22.413; P > .99]). Soft-tissue reaction occurred in 0 patients in the ePTFE-only group vs 1 patient (3%) in the ePTFE with conchal cartilage group (soft-tissue reaction rate [OR, 0.000; 95% CI, 0.000-8.538; P = .49]). Irregularity occurred in 0 patients in the ePTFE-only group vs 3 patients (8%) in the ePTFE with conchal cartilage group (irregularity rate [OR, 0.000; 95% CI, 0.000-1.066; P = .11]). Extrusion occurred in neither of the 2 groups. Conclusions and Relevance A new technique using ePTFE alone for augmentation of the nasal tip and nasal dorsum achieved safe, attractive, and acceptable outcomes in nasal contouring and patient satisfaction. The use of conchal cartilage as a shield in the nasal tip is not necessary. Level of Evidence 1. Trial Registration Chinese Clinical Trial Registry identifier: ChiCTR-INR-17011101