NCT01225250

Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty

An Open-Label, Randomized, 2-Arm Parallel Study Comparing the Efficacy, Ease of Use, and Safety of PDS Plated Cartilagenous Grafting Versus Non-Plated Cartilagenous Grafting as Performed Through Endonasal Rhinoplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: DeNova Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft.

Conditions

• Rhinoplasty

Interventions

Type	Name	Description
DEVICE	Polydioxanone (PDS) plates	0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.
PROCEDURE	Caudal septal extension graft performed through endonasal rhinoplasty	The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.
PROCEDURE	Caudal septal extension graft performed through endonasal rhinoplasty	The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.

Timeline

• Start date: 2010-11-24
• Primary completion: 2015-01-19
• Completion: 2015-01-19
• First posted: 2010-10-20
• Last updated: 2020-11-04
• Results posted: 2020-11-04

Locations

1 site across 1 country: United States