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CTRI Number  CTRI/2025/03/082974 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 30/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on Chitosan for Reducing Bleeding in Patients Undergoing Oral and Facial Surgery. 
Scientific Title of Study   Efficacy of chitosan-based material for hemostasis of orofacial incisions: A randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smit Parmar 
Designation  Post Graduate Student 
Affiliation  AIIMS RAIPUR 
Address  Dr. Smit Parmar Post Graduate - Junior Resident Department of Dentistry All India Institute of Medical Sciences, Raipur
-
Raipur
CHHATTISGARH
492099
India 
Phone  9723519467  
Fax  -  
Email  smitparmar1209@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nakul Uppal 
Designation  Professor, Oral and maxillofacial surgery, Department of Dentistry 
Affiliation  AIIMS RAIPUR 
Address  Department of Dentistry, All India Institute of Medical Sciences (AIIMS), Raipur G.E. Road, Tatibandh, Raipur, Chhattisgarh – 492099, India.

Raipur
CHHATTISGARH
492099
India 
Phone  9845628027  
Fax  -  
Email  nakuluppal@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Smit Parmar 
Designation  Post Graduate Student 
Affiliation  AIIMS RAIPUR 
Address  Department of Dentistry, All India Institute of Medical Sciences (AIIMS), Raipur G.E. Road, Tatibandh, Raipur, Chhattisgarh – 492099, India.

Raipur
CHHATTISGARH
492099
India 
Phone  9723519467  
Fax  -  
Email  smitparmar1209@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Raipur G.E. Road, Tatibandh, Raipur, Chhattisgarh – 492099, India. 
 
Primary Sponsor  
Name  Dr Smit Parmar 
Address  Dr. Smit Parmar Post Graduate - Junior Resident Department of Dentistry, All India Institute of Medical Sciences (AIIMS), Raipur G.E. Road, Tatibandh, Raipur, Chhattisgarh – 492099, India. 
Type of Sponsor  Other [Self] 
 
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 
Dr Smit Parmar  All India Institute of Medical Sciences (AIIMS), Raipur  Department of Dentistry, C- Block, AIIMS Raipur, Tatiband, Raipur, Chattisgarh-492011, India
Raipur
CHHATTISGARH 
9723519467
-
smitparmar1209@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute Of Medical Sciences, Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K099||Cyst of oral region, unspecified, (2) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (3) ICD-10 Condition: S026||Fracture of mandible, (4) ICD-10 Condition: S022||Fracture of nasal bones, (5) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chitosan Based hemostatic Agent  Chitosan-based hemostatic agent will be applied on Oro - Facial Incisions given during surgery, and the duration and quality of hemostasis will be evaluated.The endpoint of each group will be 5 minutes after 5 minutes quality of hemostasis is noted. 
Comparator Agent  Cotton gauze  Plain cotton gauze will be used for pressure packing over the orofacial incisions as a comparator group and the degree of hemostasis will be evaluated after 5 minutes degree of hemostasis is noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:-
1. Patients scheduled for elective surgery involving orofacial incisions to be placed in the maxillofacial region.
2. Of ages 18 years and above.
3. Able to provide informed consent
 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1. Patients with bleeding disorders or coagulopathies.
2. Patients on anti-coagulants.
3. Hypertensive patients whose systolic blood pressure (SBP) exceeds 160 mmHg.8
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate whether chitosan application in elective incisions reduces hemostatic time when used against a control.  In this study, intraoperative hemostasis will be assessed at specific time points. Bleeding severity will be evaluated using the Boezaart Surgical Field Grading Scale before and after applying the hemostatic agent. Hemostasis time will be recorded every 30 seconds after 2 minutes of application till 5 minutes in each group, and reactionary bleeding or additional interventions will be documented after 5 minutes if required. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To quantify the degree of hemostasis obtained by chitosan application using a standardised scale.
2. To assess presence or absence of reactionary bleeding after removal of chitosan hemostatic material.
 
Degree of bleeding & reactionary bleeding or additional interventions will be documented after 5 minutes of application of the chitosan based hemostatic material or Cotton gauze on incision. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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/ Phase 3 
Date of First Enrollment (India)   31/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In surgeries involving the face and mouth, controlling bleeding effectively is crucial due to the high number of blood vessels in these areas. Traditional methods and materials to stop bleeding can sometimes be slow, ineffective, or cause side effects. This research focuses on a new type of material made from chitosan, a natural substance derived from the shells of crustaceans like shrimp and crabs, known for its ability to quickly stop bleeding and being safe for use in the body.

The study aims to test how well chitosan-based materials work in controlling bleeding during and after oral and facial surgeries. The research will compare the new chitosan material with conventional hemostatic agents to see which one works better, how quickly they stop the bleeding, and if they cause any adverse reactions. The goal is to gather scientific evidence that could prove the chitosan material is a better option for surgeons.

If successful, this research could significantly impact the way bleeding is managed in oral and facial surgeries. It could lead to quicker surgeries, fewer complications, and faster recovery times for patients. This would not only benefit individual patients by improving their surgical outcomes but also help healthcare providers by making surgeries more efficient and reducing costs associated with complications and prolonged surgeries.

This study is important for improving surgical techniques and patient care in local hospitals and clinics, and its findings could influence national healthcare practices and policies. Additionally, the results could have a global impact, providing a new, effective solution for managing surgical bleeding in facial and oral procedures worldwide.

By proving the effectiveness of chitosan-based hemostatic materials, this research aims to set a new standard in surgical care, benefiting patients and healthcare systems both locally and globally.

 

 
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