Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
This trial is active, not recruiting.
|Treatments||polydioxanone (pds) plates, caudal septal extension graft performed through endonasal rhinoplasty|
|Collaborator||Mentor Worldwide, LLC|
|Start date||November 2010|
|End date||April 2015|
|Trial size||30 participants|
|Trial identifier||NCT01225250, PDS-END-001|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
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
time frame: 12 months post surgery
time frame: During surgery
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.
|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|
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