Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
NCT ID: NCT01225250
Last Updated: 2020-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2010-11-24
2015-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polydioxanone (PDS) plates
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.
Non-plated cartilagenous graft
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.
Interventions
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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.
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 Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Mentor Worldwide, LLC
INDUSTRY
DeNova Research
OTHER
Responsible Party
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Steven H. Dayan
Medical Director
Principal Investigators
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Steven H Dayan, MD
Role: PRINCIPAL_INVESTIGATOR
DeNova Research/ Chicago Center for Facial Plastic Surgery
Locations
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DeNova Research
Chicago, Illinois, United States
Countries
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References
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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.
Related Links
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DeNova Research
Dr. Steven H. Dayan, MD FACS
Other Identifiers
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PDS-END-001
Identifier Type: -
Identifier Source: org_study_id