Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty

DeNova Research

Status: Completed

Conditions: Rhinoplasty

Treatments: Procedure: Caudal septal extension graft performed through endonasal rhinoplasty; Device: Polydioxanone (PDS) plates

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01225250

PDS-END-001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Polydioxanone (PDS) plates

Experimental group

Description:

15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft

Treatment:

Procedure: Caudal septal extension graft performed through endonasal rhinoplasty

Procedure: Caudal septal extension graft performed through endonasal rhinoplasty

Device: Polydioxanone (PDS) plates

Non-plated cartilagenous graft

Other group

Description:

15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft

Treatment:

Procedure: Caudal septal extension graft performed through endonasal rhinoplasty

Procedure: Caudal septal extension graft performed through endonasal rhinoplasty