Head to Head Comparison of Chitodex Gel With Triamcinolone vs NexFoam With Triamcinalone on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis (CRS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Clinical Scores on Endoscopy
研究概览
简要总结
The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.
详细描述
The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
- •≥ 18 years to ≤ 90 years AND
- •English speaking AND
- •Able to give written informed consent AND
- •Local residents who will be returning to this center for postoperative follow-up care AND
- •Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 & 12 (± 2) weeks post-op.
排除标准
- •allergy to shellfish
- •pregnant or breastfeeding
- •Hepatitis or blood disorders
- •any drug allergy
- •allergy to potato starch (due to Nexfoam)
结局指标
主要结局
Clinical Scores on Endoscopy
时间窗: 12 (±2) weeks post surgery
Outcome measured based on the wound healing in the sinus openings made during surgery.
次要结局
- Symptom Scores on Patients' Self-Directed Questionnaires(12 (±2) weeks post surgery)
研究者
Joseph Brunworth, MD
Assistant Professor
St. Louis University