Clinical trial NCT01225250: Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinoplasty
Keywords: Caudal septal extension graft
Primary rhinoplasty
Secondary rhinoplasty
Lead sponsor: DeNova Research
Sponsor class: OTHER
Collaborators: name: Mentor Worldwide, LLC
First posted: 2010-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Live Assessment of Satisfaction With the Grafts
timeFrame: 12 months post operative
measure: Assessment of Tip Projection
timeFrame: 12 months Post opeartive
measure: Non-treating Blinded Evaluator Satisfaction Assessment
timeFrame: Assessed at baseline, 1 month, 3 months, 6 months, and 12 months; Month 12 reported
measure: Ease of Use
timeFrame: 1 hour following surgery
Secondary outcomes:
measure: Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months
timeFrame: 12 months post surgery
measure: Intraoperative Duration
timeFrame: During surgery (up to 3 hours)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research/ Chicago Center for Facial Plastic Surgery
name: Steven H Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.