Prospective evaluation of a nonsurgical device for rhinoplasty.

[BACKGROUND] Rhinoplasty represents one of the most challenging and frequently performed procedures in plastic surgery and non-surgical rhinoplasty is rarely considered. The aim of this study was to investigate whether the Nasella Nose Former (NNF), a newly developed non-surgical rhinoplasty device, could improve objective and subjective results following surgical rhinoplasty and even correct the shape of the nose without any surgery at all.

[METHODOLOGY] In this prospective, monocentric, two-armed, non-blinded randomized, controlled clinical trial, a total of 43 participants were included. In the Surgical group, 22 patients undergoing open or closed rhinoplasty with osteotomies were randomised based on their birth year; 15 of them got to wear the NNF over 8 weeks postoperatively and 7 patients getting surgery without the NNF formed the control group. In the Cosmetic group, 21 participants wore the NNF without surgery over 14 months. At every follow-up exam, angles for crookedness, nasal hump and width were measured, the investigator assessed the patients nose and asked for patient satisfaction using a Likert-scale.

[RESULTS] Patients in the Surgical group wearing the NNF did not show any significant difference concerning objective measurements, investigator assessments and patient satisfaction compared to those not wearing the NNF. In the Cosmetic group, participants did not show objective improvements in measurements and investigator assessment. However, participants were significantly more satisfied after 14 months with their nasal back, nasal axis and outer nose in general.

[CONCLUSIONS] Considering the results of this study, we conclude that this perfectly customised external device to enhance surgical rhinoplasty outcomes or correct the shape of the nose without surgery does not seem to be effective and that further investigations in this field are not meaningful.