Status:
COMPLETED
Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
Lead Sponsor:
DeNova Research
Collaborating Sponsors:
Mentor Worldwide, LLC
Conditions:
Rhinoplasty
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01225250
Start Date
November 24 2010
End Date
January 19 2015
Last Update
November 4 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
DeNova Research
Chicago, Illinois, United States, 60611