NCT00708071已完成2 期
An Exploratory Phase 2 Clinical Study to Evaluate Efficacy and Safety of the Adjuvant Use of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) in Subjects Undergoing Rhytidectomy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Visual Comparison of Ecchymosis at Postoperative Day 3
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).
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 (Outcomes Assessor)
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
- •Subjects planned for facial rhytidectomy
- •Subjects who read, understand and sign the written informed consent
- •Healthy female or male subjects as determined by the investigator using standard pre-operative assessments to include laboratory tests and ECG
- •Subjects 18-75 years old, inclusively
- •Subjects who are able and willing to comply with the protocol requirements
- •Female subjects of childbearing potential with a negative urine or serum pregnancy test within 72 hours of surgery
排除标准
- •Pregnant or lactating women
- •Subjects who have undergone previous face-lift surgery
- •Subjects undergoing abbreviated face-lift procedures such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
- •Subjects indicated for concurrent facial surgeries during the operation (e.g. forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
- •Subjects indicated for additional procedures during the same operation (e.g., liposuction, mastoplasty etc.)
- •Subjects who had prior silicone injections to their face (Botox and/or Restylane are allowed)
- •Subjects considered by the investigator to be smokers
- •Subjects with ecchymosis and/or edema on the face on day 0, prior to surgery
- •Subjects with known (documented) bleeding or coagulation disorders
- •Subjects currently being treated with anti-coagulants
- •Subjects treated with Aspirin in the last 7 days or use of other Non-steroidal anti-inflammatory drug (NSAIDs) within the last 7 days prior to surgery
- •Subjects with vascular disorders, cardiovascular disease, and/or uncontrolled hypertension
- •Subjects with diabetes mellitus
- •Subjects with a history of Bell´s palsy
- •Subjects with connective tissue disorders
- •Subjects with documented history of pathologically or pharmacologically induced immune deficiency
- •Subjects receiving systemic corticosteroid treatment for a chronic condition within 2 to 30 days prior to the surgery
- •Subjects with a known sensitivity to fibrin sealants
- •Subjects with a known psychiatric disorder (e.g., depression, obsessive compulsive disorder, anxiety, eating disorders, etc)
- •Subjects who have participated in another clinical study within 30 days prior to this study
研究组 & 干预措施
1
Experimental
One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
干预措施: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) (Biological)
结局指标
主要结局
Visual Comparison of Ecchymosis at Postoperative Day 3
时间窗: Through Postoperative Day 3
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period
时间窗: Through Postoperative Day 14 (± 1)
次要结局
- Visual Comparison of Ecchymosis at Day 1(Through Postoperative Day 1)
- Visual Comparison of Ecchymosis at Day 5(Through Postoperative Day 5)
- Visual Comparison of Ecchymosis at Day 7(Through Postoperative Day 7)
- Visual Comparison of Ecchymosis at Day 10(Through Postoperative Day 10)
- Visual Comparison of Ecchymosis at Day 14(Through Postoperative Day 14)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1(Through Postoperative Day 1)
- Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14(Postoperative Days 3, 7, 10, and 14)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3(Through Postoperative Day 3)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5(Through Postoperative Day 5)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7(Through Postoperative Day 7)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10(Through Postoperative Day 10)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14(Through Postoperative Day 14)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3(Postoperative Day 3)
- Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1(Through Postoperative Day 1)
- Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3(Through Postoperative Day 3)
- Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5(Through Postoperative Day 5)
- Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7(Through Postoperative Day 7)
- Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10(Through Postoperative Day 10)
- Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14(Through Postoperative Day 14)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1(Through Postoperative Day 1)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3(Through Postoperative Day 3)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5(Through Postoperative Day 5)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7(Through Postoperative Day 7)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10(Through Postoperative Day 10)
- Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14(Through Postoperative Day 14)
- Resolution of Ecchymosis as Assessed by Investigators(Postoperative Days 1, 3, 5, 7, 10, and 14)
- Resolution of Edema as Assessed by Investigators.(Postoperative Days 1, 3, 5, 7, 10, and 14)
- Total Volume of Drainage on Each Side of the Face(24 hours postoperative)
- Participants With Hematoma/Seroma(Days 0, 1, 3, 5, 7,10, and 14)
- Participants With Hematoma/Seroma During the Study(Through Postoperative Day 14 (± 1))
- Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)(Days 1, 3, 5, 7,10, and 14)
- Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)(Days 1, 3, 5, 7,10, and 14)
- Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)(Postoperative Days 1, 3, 5, 7, 10, and 14)
研究者
研究点 (6)
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