Rates of Middle Meatus (MM) Synechiae Formation Post Endoscopic Sinus Surgery (ESS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate).
研究概览
简要总结
The study is designed to evaluate if addition of the steroid to the spacer / stent will improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.
详细描述
The study is designed to evaluate basic device usability and confirm safety and effectiveness of the Restora Steroid Eluting spacer compared to a Silastic spacer.
At the completion of their procedure, patients undergoing ESS will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without drug placed on the other side. Patients will return for standard post-op visits. Between post-op day 6 and 8, both spacers will be removed. Patients will again be seen on post-op day 35 and 90 to evaluate the surgical sites with respect to healing, scarring, infection, degree of inflammation, polyp formation, and the need for secondary intervention. Data from the two sides will be compared to determine if there is a benefit derived from the spacer with steroid vs the one without.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
At the end of surgery, the Surgery Fellow will insert either the Drug Eluting Spacer or the Silastic spacer into each side of the subject's nose. The subject will receive one of each spacer. The fellow will record which spacer was placed on which side using a special coding system to keep this information private. This maintains the blinding for the primary surgeon/outcome assessor and subject.
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
- 否
入选标准
- •Age between 18 and 75 years
- •Diagnosis of chronic rhinosinusitis (CRS), per current guidelines
- •Patients who need to undergo primary bilateral complete endoscopic sinus surgery
- •Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments
- •Subject must understand the research nature of this study and sign an informed consent prior to the performance of any study-specific procedure or assessment
- •Exclusion Criteria
- •Subject is pregnant or breast feeding
- •Patients with sino-nasal tumors
- •Patients solely undergoing nasal septal reconstruction
- •Patients with previous history of endoscopic sinus surgery
- •Cystic fibrosis or syndromic patients
- •Patients with autoimmune diseases
- •Patients who have taken oral steroids less than 30 days prior to surgery
- •Patients with a history or diagnosis of glaucoma or ocular hypertension
- •Any other circumstance or condition that in the Investigator's opinion causes the subject to be an inappropriate candidate for participating in this study
排除标准
- 未提供
研究组 & 干预措施
Steroid Eluting Spacer
Subjects will receive one steroid eluting spacer (Restora Mometasone Furate Eluting Spacer) placed into the surgical site on one side, and one spacer without drug (Silastic spacer) placed on the other side.
The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.
干预措施: steroid eluting spacer (Device)
结局指标
主要结局
Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate).
时间窗: 35 to 90days
Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.
次要结局
未报告次要终点
研究者
Peter Catalano
Director otolaryngology
Steward St. Elizabeth's Medical Center of Boston, Inc.