Medicated Punctured-Glove-Finger Spacer Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post-operative endoscopic appearance
研究概览
简要总结
All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy the inclusion/exclusion criteria will be included in the study.
All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as their own controls. Nostril's will be randomized to either the experimental treatment (Triamcinolone-impregnated spacer) or the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op.
Participants will undergo the standard post-operative endoscopic sinus surgery follow-up appointments plus one additional research visit (not standard of care). This includes follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the post-operative period. During these appointments, the surgeon will assess the post-operative mucosal appearance (Philpott-Javer Sinus Rating System). SNOT-22 surveys will be administered, as per standard protocol, at each post-op follow up visit.
Sinus tissue biopsies will be taken from both meati on 28-day and 3-month post-op follow-up appointments for analysis.
Our objective is to determine if triamcinolone soaked Merocel middle meatus spacers (MMS) in a perforated glove finger improves patient outcomes, wound healing and reduces inflammation compared to a standard saline-soaked merocel sponge within a perforated glove finger in CRS patients receiving FESS.
Our hypothesis is that triamcinolone-medicated Merocel MMS are not inferior to standard saline-soaked spacers, when both are enclosed in a perforated surgical glove finger.
详细描述
Patients suffering from chronic rhinosinusitis undergoing Functional Endoscopic Sinus Surgery (FESS) require nasal spacers to be inserted intra-operatively into the middle-meatus to prevent lateralization of the middle turbinate and subsequent scarring and adhesions. Nasal spacers can be impregnated with topical steroids to assist in post-surgical recovery. Our centre is now investigating the effect of triamcinolone-medicated nasal spacers placed inside a punctured glove finger to improve wound healing.
All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as their own controls. One nostril will receive the experimental treatment (Triamcinolone-impregnated spacer) and one will receive the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op.
Randomization of patients' nostrils to a treatment arm will occur on the day of surgery based on a closed envelope system.
Participants will undergo the standard post-operative endoscopic sinus surgery follow-up appointments plus one additional research visit (not standard of care). This includes follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the post-operative period. The 14-day follow-up appointment is an additional visit not included as standard practice at our centre. However, study patients will have this added visit in order to closely observe their recovery and endoscopic evaluation. During these appointments, the surgeon will assess the post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain, and 1st week post-operative bleeding (only at 6 day visit).
The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study participants at 6 days, 14 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a 5-minute questionnaire consisting of 22 questions, which asks participants to rate their sinus symptoms and social/emotional consequences of their nasal disorder from "no problem" to "problem as bad as it can be."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All CRS patients undergoing bilateral endoscopic surgery requiring spacers
排除标准
- •Patients under the age of 19
- •Patients unable to understand English
- •Patients who are pregnant
- •Patients with known bleeding disorders
- •Patients with systemic disorders affecting the nose
- •Patients in another concurrent study
- •Unilateral endoscopic sinus surgery
- •Surgery in which spacers are not needed
- •Patients undergoing sinonasal tumour resection
- •Patients who cannot tolerate or are allergic to triamcinolone
研究组 & 干预措施
Saline-impregnated spacer
Saline-impregnated spacers are actively being used as the standard of care. It does not contain any active ingredients.
干预措施: Saline-impregnated spacer (Other)
Triamcinolone-impregnated spacer
This study arm receives the experimental treatment, a Triamcinolone-impregnated spacer.
干预措施: Triamcinolone (Drug)
结局指标
主要结局
Post-operative endoscopic appearance
时间窗: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Participants in the study have their sinus cavities assessed by rigid endoscopy and mucosa graded by the Lund-Kennedy and Philpott-Javer scaling system. Each sinus cavity (frontal, ethmoid, maxillary and sphenoid) and olfactory cleft will be given a score between zero and nine, with an extra point for the presence of fungal mucin, achieving a total potential maximum out of fifty per side (14).
Post-operative inflammation
时间窗: Biopsies will be removed during a 3 month period (beginning the day of surgery)
Participants will have biopsies taken from both middle meati in contact with nasal packing. Biopsies will be assessed and scored with a previously utilized histologic scoring system at our centre in order to determine the level of inflammation between the triamcinolone-medicated and saline-soaked spacers.
次要结局
- Post-Operative SNOT-22(Participants will be followed for the duration of post op standard of care, an expected average of 6 months.)
研究者
Amin Javer
MD, FRCSC FARS
St. Paul's Hospital, Canada