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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Mentor Worldwide, LLC
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research
ClinicalTrials.gov Identifier:
NCT01225250
First received: October 19, 2010
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Rhinoplasty
Device: Polydioxanone (PDS) plates
Procedure: Caudal septal extension graft performed through endonasal rhinoplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by DeNova Research:

Primary Outcome Measures:
  • Live assessment of satisfaction with the grafts [ Time Frame: 12 months post operative ] [ Designated as safety issue: No ]
    Efficacy will be determined by a live assessment of satisfaction with the grafts at 12 months using a four-point categorical satisfaction scale (unsatisfied, satisfied, very satisfied, highly satisfied).

  • Assessment of Tip Projection [ Time Frame: 12 months Post opeartive ] [ Designated as safety issue: No ]
    Tip projection will be measured as a ratio between a fixed distance established by the anterior most point of the intertragal notch to the anterior most portion of the cornea and a variable distance established by the distance between the anterior most point of the intertragal notch to the nasal tip using measurements recorded from Adobe Photoshop evaluation of standardized photography at 12 months postoperatively as compared to baseline.

  • Non-treating blinded evaluator satisfaction assessment [ Time Frame: 12 months post operative ] [ Designated as safety issue: No ]
    A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale (unsatisfied, satisfied, very satisfied, 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.

  • Ease of use [ Time Frame: 1 hour following surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety [ Time Frame: 12 months post surgery ] [ Designated as safety issue: Yes ]
    Safety will be determined by rate of infection, rejection, and extrusion of the graft at 1 week, 1 month, 3 months, 6 months, and 12 months.

  • Intraoperative Duration [ Time Frame: During surgery ] [ Designated as safety issue: No ]
    Intraoperative duration of the grafting procedure will be measured by an assistant using a stopwatch to record the time it takes to harvest, shape, and satisfactorily secure the graft.


Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polydioxanone (PDS) plates
15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft
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.
Non-plated cartilagenous graft
15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225250

Locations
United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
DeNova Research
Mentor Worldwide, LLC
Investigators
Principal Investigator: Steven H Dayan, MD DeNova Research/ Chicago Center for Facial Plastic Surgery
  More Information

Additional Information:
No publications provided

Responsible Party: Steven H. Dayan, Medical Director, DeNova Research
ClinicalTrials.gov Identifier: NCT01225250     History of Changes
Other Study ID Numbers: PDS-END-001
Study First Received: October 19, 2010
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by DeNova Research:
Caudal septal extension graft
Primary rhinoplasty
Secondary rhinoplasty

ClinicalTrials.gov processed this record on October 23, 2014