safety and efficacy study of polydioxanone (pds) plates in rhinoplasty

Conditions: Rhinoplasty

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.

Keywords: caudal septal extension graft primary rhinoplasty secondary rhinoplasty