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CTRI Number  CTRI/2024/03/064416 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 18/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Injection Botulinum Toxin in post-surgery wound healing 
Scientific Title of Study   Intraglandular Botulinum Toxin (BoNT) Injection for Postoperative Head and Neck Fistula Healing: A Pilot Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Smriti Panda 
Designation  Assistant Professor 
Affiliation  A.I.I.M.S, New Delhi 
Address  Teaching Block, 4th Floor, A.I.I.M.S, New Delhi

New Delhi
DELHI
110029
India 
Phone  9717827306  
Fax    
Email  smriti.panda.87@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Smriti Panda 
Designation  Assistant Professor 
Affiliation  A.I.I.M.S, New Delhi 
Address  Teaching Block, 4th Floor, A.I.I.M.S, New Delhi

New Delhi
DELHI
110029
India 
Phone  9717827306  
Fax    
Email  smriti.panda.87@gmail.com  
 
Details of Contact Person
Public Query  
Name  Smriti Panda 
Designation  Assistant Professor 
Affiliation  A.I.I.M.S, New Delhi 
Address  Teaching Block, 4th Floor, A.I.I.M.S, New Delhi

New Delhi
DELHI
110029
India 
Phone  9717827306  
Fax    
Email  smriti.panda.87@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Early Career Intramural Grant 2023-2024 
 
Primary Sponsor  
Name  Intraumural Grant 
Address  A.I.I.M.S, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Smriti Panda  AIIMS, New Delhi  National cancer Institute, Room Number 10, Academic Block Ground Floor
Jhajjar
HARYANA 		 9717827306

smriti.panda.87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, A.I.I.M.S, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conservative management  Antibiotics+ local wound care+ oral anticholinergics. Antibiotics choice will be culture directed. Tab glycopyrrolate 2mg TDS till fistula closure  
Intervention  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 submandibular gland will be injected with 20IU divided equally in two sites. Twenty-four guage or 26G needle will be chosen for the procedure. The choice of gland will be based on extent of surgical resection as patients undergoing neck dissection of level 1 as part of selective or radical neck dissection undergo excision of submandibular gland. Maximum dose of BoNT will not exceed 100IU based on the literature review. A single injection session is planned for this study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time taken for fistula to heal from date of onset of fistula till date of healing of fistula  Time taken for fistula to heal.
Single time point at which fistula is dry 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   31/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [smriti.panda.87@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

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.

 
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