Intraglandular Botulinum Toxin (BoNT) Injection for Postoperative Head and Neck Fistula Healing: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time taken for fistula to heal from date of onset of fistula till date of healing of fistula
研究概览
简要总结
In the present study we intend to study the efficacy of a uniform standardized regime of intraglandular BoNT injection in reducing the time to healing of fistula in patients with postoperative head and neck fistula. The intervention will be compared with conventional conservative management in the setting of a randomized controlled trial. If the results of this trial show a clinically meaningful difference between intervention and control in terms of time to fistula healing, this would in turn translate to shorter hospital stay, faster initiation of oral feeds and timely initiation of adjuvant treatment. Due to existing lacuna about dosing of BoNT and evidence being derived from limited single institution experiences, the present study protocol could provide answers to most of these unanswered questions.
Intraglandular BoNT has been proven to decrease salivary flow rates by 40% when injected into both the parotid glands in patients with sialorrhea in the background of neurodegenerative disorders. Due to this mechanism of action we hypothesize that injecting BoNT in major salivary glands in patients developing postoperative fistula will result in faster healing of fistula. A difference of 10 days in time to healing will be considered as clinically meaningful reduction in fistula healing time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of head and neck cancer presenting with either orocutaneous fistula or pharyngocutaneous following surgery for upper aerodigective tract tumours
- •Size of fistula between 10mm to 20mm.
排除标准
- •Patients unwilling to give written informed consent
- •Patients with prior history of head and neck radiation and radiorecurent tumours
- •Fistula less than 10mm or greater than 20 mm.
结局指标
主要结局
Time taken for fistula to heal from date of onset of fistula till date of healing of fistula
时间窗: Time taken for fistula to heal. | Single time point at which fistula is dry
次要结局
- Reduction of salivary output at the fistula(number of fully soaked gauze pieces measured every 24 hours till fistula closure)
- Subjective reduction in salivary flow rate(100% (normal salivary flow rate) to 0% (no salivation) measured every week till 4 weeks)
- Adverse effects on intraglandular BoNT(followed up till 4 weeks after injection)
研究者
Smriti Panda
A.I.I.M.S, New Delhi