A Study on Chitosan for Reducing Bleeding in Patients Undergoing Oral and Facial Surgery.

Efficacy of chitosan-based material for hemostasis of orofacial incisions: A randomised controlled trial - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082974

Enrollment

Registered

2025-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K099- Cyst of oral region, unspecified Health Condition 2: S024- Fracture of malar, maxillary and zygoma bones Health Condition 3: S026- Fracture of mandible Health Condition 4: S022- Fracture of nasal bones Health Condition 5: O- Medical and Surgical

Interventions

Intervention1: 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 evalu

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To estimate whether chitosan application in elective incisions reduces hemostatic time when used against a control.Timepoint: 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.	—

Measure

Time frame

To estimate whether chitosan application in elective incisions reduces hemostatic time when used against a control.Timepoint: 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.

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Secondary

Measure	Time frame
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. Timepoint: 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.	—

Measure

Time frame

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. Timepoint: 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.

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Countries

India

Contacts

Public ContactDr Smit Parmar

AIIMS RAIPUR

nakuluppal@aiimsraipur.edu.in9845628027

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026