A Prospective, Double-Blinded, Randomized Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Edema Severity
研究概览
简要总结
Rhinoplasty (nasal reconstruction i.e. "a nose job") is a surgical procedure performed on the nose to correct a medical problem or change the appearance of the nose. During the healing process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may or may not lessen these effects. This study is looking to see the effects of ARTISS on adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an external approach.
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
- Double (Participant, 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 rhinoplasty and requiring an external approach.
- •Subjects willing to undergo treatment with fibrin sealant.
- •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 who are planning a concurrent facial surgery during the operation (eg forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.).
- •Subjects with a previous history of rhinoplasty.
- •Subjects with a current history of smoking.
- •Subjects with a previous history of a bleeding or coagulation disorder .
- •Subject with a previous history of a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension.
- •Subjects a previous history of diabetes mellitus with glycosylated hemoglobin (HbA1c) >
- •Subjects undergoing active treatment for a malignancy.
- •Subjects with a previous history of has a connective tissue disorder.
- •Subjects with active or chronic skin disorder.
- •Subjects with a previous history of Bell's palsy.
- •Subjects with a previous history of pathologically or pharmacologically induced immune deficiency.
- •Subjects who have received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery.
- •Subjects with a known sensitivity to components of FS VH S/D 4 s-apr.
- •Subjects with a previous history of healing complications following previous surgeries (eg, hypertrophic scarring).
- •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.
- •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.
- •Subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study
研究组 & 干预措施
ARTISS Human Fibrin Sealant
Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.
干预措施: ARTISS human fibrin sealant (Biological)
Standard of Care
Fixation of the skin flap created during external rhinoplasty will use the standard of care
结局指标
主要结局
Edema Severity
时间窗: Measured at Day 1, 7, 30, 180
Measured at Day 1, 7, 30, 180 0 None- No apparent edema 1. Mild- Minimal tissue swelling 2. Moderate- Moderate edema, nasal features still discernible 3. Severe- Marked swelling, difficulty distinguishing nasal features Scores closer to 0 indicate more favorable results
Median Number of Adverse Events
时间窗: 1 day, 1 week, 4 weeks and 6 months following surgery
Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary.
次要结局
- HPSS Assessment(1 week, 4 weeks and 6 months following surgery)
- Ease of Use(Immediately Post Surgery)
- Objective Ecchymosis Evaluation - PI(6 months)
- Subject Downtime Questionnaire(1 day, 1 week, 4 weeks and 6 months following surgery)
- Blinded-assessment of Satisfaction(Measured at Baseline, 1 month, 3 months, 6 months, 12 months)
- Number of Participants With Adverse Events(Day 30)
- Subjective Ecchymosis Evaluation - Subject(6 months)
研究者
Steven H. Dayan
Medical Director
DeNova Research