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

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 24, 2010

Primary Completion Date

January 19, 2015

Study Completion Date

January 19, 2015

Conditions
Rhinoplasty
Interventions
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.

Trial Locations (1)

60611

DeNova Research, Chicago

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Mentor Worldwide, LLC

INDUSTRY

lead

DeNova Research

OTHER