Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty (NCT01225250) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
United States30 participantsStarted 2010-11-24
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 in…