An Open-Label, Randomized, 2-Arm Parallel Study Comparing the Efficacy, Ease of Use, and Safety of PDS Plated Cartilagenous Grafting Versus Non-Plated Cartilagenous Grafting as Performed Through Endonasal Rhinoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Live Assessment of Satisfaction With the Grafts
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Live Assessment of Satisfaction With the Grafts
时间窗: 12 months post operative
Efficacy will be determined by a live assessment of satisfaction with the grafts at 12 months using a four-point categorical satisfaction scale ((4) unsatisfied, (3) satisfied, (2) very satisfied, (1) highly satisfied). Scores closer to 1 indicate a more favorable outcome
Assessment of Tip Projection
时间窗: 12 months Post opeartive
Tip projection will be measured using standardized photography preoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively using Goode's Ratio. The ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be 0.55. If it is more than that the nose is over projected, if it is under that ratio the nose is under projected.
Non-treating Blinded Evaluator Satisfaction Assessment
时间窗: Assessed at baseline, 1 month, 3 months, 6 months, and 12 months; Month 12 reported
A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale ((4) - unsatisfied, (3) - satisfied, (2) - very satisfied, (1) - highly satisfied) of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site. Scores closer to 1 indicate a more favorable outcome
Ease of Use
时间窗: 1 hour following surgery
Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease with a score of 0 mm being easy and a scale of 100 mm being extremely difficult.
次要结局
- Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months(12 months post surgery)
- Intraoperative Duration(During surgery (up to 3 hours))
研究者
Steven H. Dayan
Medical Director
DeNova Research