The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity
研究概览
简要总结
The purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.
详细描述
Septorhinoplasty is a well established technique to correct nasal deformity. Drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. Swelling and bruising in and around the surgical site may persist for months after the operation. At present, there is no standard regarding the length of time nasal tape and cast should be used following septorhinoplasty. It has never been proven that taping or casting is required - in surgeries that require minimal amounts of tissue handling, we may not use any tape or cast following the procedure. Homologous fibrin glue has been used for various cosmetic facial plastic procedures since the early 1980's. It has been shown to decrease bruising and swelling following surgery. This study is being undertaken to evaluate these benefits of using fibrin glue in nasal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient over 18 years of age undergoing septorhinoplasty.
排除标准
- •Any patient having more than one procedure performed during one anesthetic.(i.e.brow lift, face lift, blepharoplasty)
研究组 & 干预措施
Control group
Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
干预措施: Septorhinoplasty (Procedure)
Control group
Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
干预措施: Taping after septorhinoplasty. (Procedure)
Control group
Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
干预措施: Cast applied to the nose after nasal surgery (Procedure)
Control group
Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
干预措施: Saline (Other)
Fibrinogen, tape, and cast
Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
干预措施: Fibrinogen (Drug)
Fibrinogen, tape, and cast
Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
干预措施: Septorhinoplasty (Procedure)
Fibrinogen, tape, and cast
Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
干预措施: Taping after septorhinoplasty. (Procedure)
Fibrinogen, tape, and cast
Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
干预措施: Cast applied to the nose after nasal surgery (Procedure)
Fibrinogen and tape
Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
干预措施: Fibrinogen (Drug)
Fibrinogen and tape
Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
干预措施: Septorhinoplasty (Procedure)
Fibrinogen and tape
Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
干预措施: Taping after septorhinoplasty. (Procedure)
结局指标
主要结局
Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity
时间窗: 6 months post operative
ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied). NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem). Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose
次要结局
- Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire(6 months postoperative)