Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Intraglandular botulinum toxin A + conservative management and oral anticholinergics: Total 40IU of BoNT divided equally at two sites will be injected in each parotid gland. Each subman
Sponsors
Intraumural Grant
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of head and neck cancer presenting with either orocutaneous fistula or pharyngocutaneous following surgery for upper aerodigective tract tumours 2. Size of fistula between 10mm to 20mm
Exclusion criteria
Exclusion criteria: 1. Patients unwilling to give written informed consent 2. Patients with prior history of head and neck radiation and radiorecurent tumours 3. Fistula less than 10mm or greater than 20 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time taken for fistula to heal from date of onset of fistula till date of healing of fistulaTimepoint: Time taken for fistula to heal. Single time point at which fistula is dry | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects on intraglandular BoNTTimepoint: followed up till 4 weeks after injection;Reduction of salivary output at the fistulaTimepoint: number of fully soaked gauze pieces measured every 24 hours till fistula closure;Subjective reduction in salivary flow rateTimepoint: 100% (normal salivary flow rate) to 0% (no salivation) measured every week till 4 weeks | — |
Countries
India
Contacts
Public ContactSmriti Panda
A.I.I.M.S, New Delhi
Outcome results
None listed