| 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
|
|
|
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
|
|
|
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. |