Effect of expanded polytetrafluoroethylene prosthesis in rhinoplasty:study protocol for a randomized controlled clinical trial
10.3969/j.issn.2095-4344.2017.06.028
- VernacularTitle:膨体聚四氟乙烯假体隆鼻整形的效果:随机对照临床试验方案
- Author:
Jianmin LI
- From:
Chinese Journal of Tissue Engineering Research
2017;21(6):980-984
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND:Costal cartilage, auricular cartilage, materials for teeth and silica gel have been widely applied in rhinoplasty, but consequent adverse events, such as rejection, prosthesis displacement and implanted skin redness make the outcomes far from satisfaction. OBJECTIVE:To explore the effect of expanded polytetrafluoroethylene prosthesis for lower dorsum with small nasal septum.METHODS/DESIGN:This was a prospective, single-central, randomized, and open-label study that finished in the Qinghai University Affiliated Hospital, China. 100 patients hospitalized in the Department of Otorhinolaryngology for rhinoplasty between January 2014 and June 2015 were enrolled, and randomized into experimental and control groups (n=50 per group). The experimental group was subjected to the polytetrafluoroethylene prosthesis implantation, while the control group received the silica gel implantation. All patients were followed up for 12 months. The primary outcome measure was the postoperative satisfaction at 12 months. The secondary outcome measures were the changes of the nasal internal structure indexes, ultrasonic results of the nasal internal soft tissues and the incidence of adverse events. This study was approved by the Ethics Committee of the Qinghai University Affiliated Hospital and in accordance with the Declaration of Helsinki, formulated by the World Medical Association. All participants had signed the informed consents prior to participation in the study. DISCUSSION:Polytetrafluoroethylene prosthesis and silica gel both exhibit high biosafety in rhinoplasty. Compared with silica gel, the polytetrafluoroethylene prosthesis can effectively adjust the nasal appearance mini-invasively and obtain satisfactory outcomes;therefore, it is expected to be a substitute of filling materials applied in nasal plastic surgery.
