MedTrace Logo

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

NCT01225250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-04

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Mentor Worldwide, LLC

    collaborator INDUSTRY

  • DeNova Research

    lead OTHER

Principal Investigators

  • Steven H Dayan, MD · DeNova Research/ Chicago Center for Facial Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-24
Primary Completion
2015-01-19
Completion
2015-01-19

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225250 on ClinicalTrials.gov