NCT00999141已完成3 期
A Randomized, Controlled Phase 3 Study to Evaluate Safety and Efficacy of Fibrin Sealant (FS) VH S/D 4 S-apr (ARTISS) to Adhere Tissues and Improve Wound Healing in Subjects Undergoing Rhytidectomy (Facelift)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Total Volume of Drainage on Each Side of the Face
研究概览
简要总结
The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subject is 18 to 75 years of age at the time of screening
- •Subject is planned for facial rhytidectomy
- •Subject has read, understood and signed the written informed consent
- •Subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms
- •Subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- •Subject is willing and able to comply with the requirements of the protocol
排除标准
- •Subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
- •Subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
- •Subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.)
- •Subject has undergone a prior rhytidectomy surgery
- •Subject is an active smoker, as assessed by the investigator
- •Subject has a known (documented) bleeding or coagulation disorder
- •Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery)
- •Subject has a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension
- •Subject has diabetes mellitus with glycosylated hemoglobin (HbA1c) > 7
- •Subject is receiving active treatment for a malignancy
- •Subject has a connective tissue disorder
- •Subject has an active or chronic skin disorder
- •Subject has history of Bell's palsy
- •Subject has a documented history of pathologically or pharmacologically induced immune deficiency
- •Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery
- •Subject has a known sensitivity to components of FS VH S/D 4 s-apr
- •Subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety, eating disorders, etc.)
- •Subject has documented healing complications following previous surgeries (eg, hypertrophic scarring)
- •Subject is pregnant or lactating at the time of enrollment
- •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
FS VH S/D 4 s-apr
Experimental
One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control.
干预措施: FS VH S/D 4 s-apr (Biological)
Standard of Care (SoC)
No Intervention
Other side of face will receive standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control.
结局指标
主要结局
Total Volume of Drainage on Each Side of the Face
时间窗: 24 hours (± 4h) after surgery
Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)
时间窗: Day 0 (day of surgery) through postoperative Day 14
次要结局
- Participants' First Occurrence of Hematoma or Seroma by Study Day(Day 0 (day of surgery) through postoperative day 14)
- Participants With Hematoma/Seroma by Study Day(Day 0 (day of surgery) through postoperative day 14)
- Number of Participants With Hematoma/Seroma Anytime During the Study(Day 0 (day of surgery) through postoperative Day 14)
- Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1(Through postoperative Day 1)
- Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3(Through postoperative Day 3)
- Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7(Through postoperative Day 7)
- Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14(Through postoperative Day 14)
- Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14(Day 0 (preoperative) through postoperative Day 14)
- Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14(Through postoperative Day 14)
- Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1(Through postoperative Day 1)
- Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3(Through postoperative Day 3)
- Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7(Through postoperative Day 7)
- Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14(Through postoperative Day 14)
- Reasons for Participants' Preferences for Side of Face(Through postoperative Day 14)
研究者
研究点 (6)
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