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

NCT01225250 | Completed Results

• 1 other identifier: PDS-END-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Caudal septal extension graft; Primary rhinoplasty; Secondary rhinoplasty

Outcome Measures

Primary Outcomes (4)

• Live Assessment of Satisfaction With the Grafts

  Efficacy will be determined by a live assessment of satisfaction with the grafts at 12 months using a four-point categorical satisfaction scale ((4) unsatisfied, (3) satisfied, (2) very satisfied, (1) highly satisfied). Scores closer to 1 indicate a more favorable outcome

  12 months post operative

• Assessment of Tip Projection

  Tip projection will be measured using standardized photography preoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively using Goode's Ratio. The ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be 0.55. If it is more than that the nose is over projected, if it is under that ratio the nose is under projected.

  12 months Post opeartive

• Non-treating Blinded Evaluator Satisfaction Assessment

  A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale ((4) - unsatisfied, (3) - satisfied, (2) - very satisfied, (1) - highly satisfied) of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site. Scores closer to 1 indicate a more favorable outcome

  Assessed at baseline, 1 month, 3 months, 6 months, and 12 months; Month 12 reported

• Ease of Use

  Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease with a score of 0 mm being easy and a scale of 100 mm being extremely difficult.

  1 hour following surgery

Secondary Outcomes (2)

• Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months

  12 months post surgery

• Intraoperative Duration

  During surgery (up to 3 hours)

Study Arms (2)

Polydioxanone (PDS) plates

EXPERIMENTAL

15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft

Device: Polydioxanone (PDS) plates; Procedure: Caudal septal extension graft performed through endonasal rhinoplasty

Non-plated cartilagenous graft

OTHER

15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft

Procedure: Caudal septal extension graft performed through endonasal rhinoplasty

Interventions

Polydioxanone (PDS) plates DEVICE

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.

Polydioxanone (PDS) plates

Caudal septal extension graft performed through endonasal rhinoplasty PROCEDURE

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.

Polydioxanone (PDS) plates

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DeNova Research: lead
• Mentor Worldwide, LLC: collaborator

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Dayan SH, Ashourian N. Polydioxanone Absorbable Plate for Cartilaginous Grafting in Endonasal Rhinoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2016 Jan-Feb;18(1):47-53. doi: 10.1001/jamafacial.2015.1492.

  PMID: 26501937 DERIVED

Related Links

• DeNova Research
• Dr. Steven H. Dayan, MD FACS

MeSH Terms

Interventions

Bone Plates

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Results Point of Contact

• Title: Steven Dayan, MD
• Organization: DeNova Research

sdayan@drdayan.com

3123352070

Study Officials

• Steven H Dayan, MD

  DeNova Research/ Chicago Center for Facial Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: November 24, 2010
• Primary Completion: January 19, 2015
• Study Completion: January 19, 2015
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-10

Locations

US (1)