Overview

This trial is active, not recruiting.

Condition rhinoplasty
Treatments polydioxanone (pds) plates, caudal septal extension graft performed through endonasal rhinoplasty
Phase phase 4
Sponsor DeNova Research
Collaborator Mentor Worldwide, LLC
Start date November 2010
End date April 2015
Trial size 30 participants
Trial identifier NCT01225250, PDS-END-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft
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.
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.
(Other)
15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft
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.

Primary Outcomes

Measure
Live assessment of satisfaction with the grafts
time frame: 12 months post operative
Assessment of Tip Projection
time frame: 12 months Post opeartive
Non-treating blinded evaluator satisfaction assessment
time frame: 12 months post operative
Ease of use
time frame: 1 hour following surgery

Secondary Outcomes

Measure
Safety
time frame: 12 months post surgery
Intraoperative Duration
time frame: During surgery

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Males and females between 18 and 65 years of age. - Subjects requesting primary or secondary rhinoplasty and requiring a CSE graft performed through an endonasal approach. - Subjects willing to undergo PDS plating. - Subjects with either ear conchal or septal cartilage available for grafting purposes. - Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. - Willingness and ability to comply with the PI's standard preoperative and postoperative rhinoplasty instructions. - Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history: - postmenopausal for at least 12 months prior to study drug administration - without a uterus and/or both ovaries - has had a bilateral tubal ligation for at least 6 months prior to study drug administration. - absence of an other physical condition according to the PI's discretion - Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup). - Willingness and ability to provide written informed consent prior to performance of any study related procedure. Exclusion Criteria: - Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control. - Subjects with a significant systemic illness or illness localized to the areas of treatment. - Subjects with previous history of nasal implants. - Subjects with previous or current history of nasal infections. - Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E) within the two weeks prior to surgery. - Subjects who have smoked within the two weeks prior to surgery. - Subjects who have had alcohol or illicit drugs one week prior to surgery. - Subjects who have eaten or drank anything after midnight the night prior to surgery. - Subjects with current history of chronic drug or alcohol abuse. - History of autoimmune disease. - Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication. - Subjects who anticipate the need for surgery, other than the study procedure, or overnight hospitalization during the study. - Subjects who, in the Investigator's opinion, have a history of poor cooperation, non compliance with medical treatment or unreliability. - Enrollment in any active study involving the use of investigational devices or drugs.

Additional Information

Official title 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
Principal investigator Steven H Dayan, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by DeNova Research.