A Multi Center, Randomized, Single Blind, Assessor Blind, Matched Pair Design Clinical Study to Evaluate the Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Difference between effective ratio (Pt=P00+P01) of medical device for clinical trial and effective ratio (Pc=P00+P10) of medical device for control test evaluated by independent assessor at the 4th week following the application of medical device
研究概览
简要总结
This clinical trial is to prove that the treatment group of Medicurtain® is non-inferior to the treatment group of Guardix-sol®, test equipment on adhesion after endoscopic sinus surgery, upon the aspects of adhesion prevention efficacy and safety.
详细描述
This clinical trial was conducted based on multi center, randomized, assessor blind, matched pair design, active-controlled clinical study. After signing consent and fulfilling the standards for selection/exclusion, test subjects went through required treatments following endoscopic surgery; subsequently, according to the order of registration after 2 to 3 days from the surgery, the subjects were applied with a medical device for the clinical test and a medical device for the control test to both of their nasal cavities based on randomization.
For procedures, bleeding was treated and prevented through packing, by soaking Merocel with saline solution following the ESS (Endoscopic sinus surgery) on subjects; and after 2 to 3 days (or upon discharge), it was to treat applied regions of the subjects with assigned medical device after confirming sufficient hemostasis by removing Merocel. Being matched pair active-controlled clinical study, this clinical trial was designed to treat a single subject with both medical devices for clinical test and control test where it was kept unknown which device would be assigned to which nasal cavity based on randomization until the procedure was actually performed. For the time and method of evaluation, observation and evaluation were allowed to be conducted based on the images through endoscopy when subjects visited at 1st, 2nd and 4th weeks following the treatment with medical device. The process of procedure was assured for an identical researcher to perform procedures in order to minimize the effect from the procedure method.
All endoscopic image records of test subjects were delivered by independent assessors, while information on medical device used for treatment was excluded; and independent assessors evaluated each image record according to the evaluation standards prescribed by this clinical trial.
Based on the determination of the researcher during and following the surgery, subjects were administered with 2nd or 3rd generation Cephalosporin Antibiotics. Following the surgery, subjects were instructed to use normal saline solution nasal spray 2 to 3 times a day on both nasal cavities by utilizing bulb-shape tube or syringe. In addition, subjects were also instructed to use intranasal steroid sprays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Evaluator-blinded
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at the age of between 19 and 69
- •Patients scheduled for surgery with chronic or relapsed sinusitis not responding to drug therapy (Verification to be made based on past clinical history, physical examination and radiography)
- •Patients with the discrepancy of Lund-MacKay CT scan scores on bilateral sinusitis less than 3
- •Patients who signed written consent after listening to the objective, method and effects of clinical trial
- •Patients available during the period of clinical trial
排除标准
- •Patients with sinusitis on only one nasal cavity
- •Patients with massive sinonasal polyposis
- •Patients with one or both middle turbinate removed, in addition to a history of endoscopic surgery or polyp operation
- •Patients with ongoing drug administration for asthma
- •Patients with immune disorders which may potentially hinder healing of the wounds including acquired immunodeficiency syndrome, cystofibroma, immotile cilia syndrome, neutropenia and immune globulin deficiency
- •Patients with immunosuppression or autoimmune disease
- •Patients with hypersensitivity reaction to Poloxamer and Hyaluronic acid
- •Patients who had surgery to treat extrasinus complication from rhinosinusitis
- •Patients with history of endoscopic sinus surgery for other than chronic or relapsed sinusitis, including cerebrospinal fluid (CSF) leak correction, orbital decompression and optic nerve decompression
- •Patients with significant liver or kidney diseases
- •Patients with setting agent administered or with hemostatic or lymph fluid disorders
- •Patients administered with oral or parenteral drugs for hypoglycemia
- •Patients with significant systematic disease
- •Patients with malignant tumor
- •Patients with infectious disease or suspected of potential problems during the course of healing surgical site (healing disorder)
- •Those who are pregnant or lactiferous
- •Women of childbearing age with plan for pregnancy during the clinical trial period
- •Those who participated in other clinical trials 30 days prior to the participation in this trial
- •In addition to the above, those who are subject to clinical findings where principal investigator or sub-investigator deem inadequate for this clinical trial based on medical judgment
研究组 & 干预措施
Medicurtain®
Treat GUARDIX-SG 5ml prefilled syringe after surgery
干预措施: Medicurtain® (Device)
GUARDIX-SG®
Treat Medicurtain® 5ml prefilled syringe after surgery
干预措施: GUARDIX-SG® (Device)
结局指标
主要结局
Difference between effective ratio (Pt=P00+P01) of medical device for clinical trial and effective ratio (Pc=P00+P10) of medical device for control test evaluated by independent assessor at the 4th week following the application of medical device
时间窗: Week 4
* P00: Ratio of study subjects without adhesion at the application site with medical devices for clinical trial and control test * P01: Ratio of study subjects without adhesion only at the application site with medical device for clinical trial * P10: Ratio of study subjects without adhesion only at the application site with medical device for control trial
次要结局
- Ratio of study subjects without edema and the extent of edema evaluated at each visit(follow up to 4weeks)
- Ratio of study subjects without local infection and extent of local infection evaluated at each visit(follow up to 4weeks)
- Presence of infection requiring treatment evaluated at each visit (Only the cases using antibiotics not for prevention purpose but for treatment purpose)(follow up to 4weeks)
- Presence of adhesion (decomposition or dissolution) requiring treatments at 4th week(follow up to 4weeks)
- Presence of edema requiring treatment evaluated at each visit (Only the cases using oral steroid not for prevention purpose but for treatment purpose)(follow up to 4weeks)
- Ratio of study subjects without adhesion and extent of adhesion evaluated by independent assessor(follow up to 4weeks)
- Ratio of study subjects without adhesion and extent of adhesion evaluated by investigator(follow up to 4weeks)