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临床试验/CTRI/2025/03/082974
CTRI/2025/03/082974招募中2/3 期

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

Dr Smit Parmar1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
To estimate whether chitosan application in elective incisions reduces hemostatic time when used against a control.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria:-
  • Patients scheduled for elective surgery involving orofacial incisions to be placed in the maxillofacial region.
  • Of ages 18 years and above.
  • Able to provide informed consent.

排除标准

  • Exclusion Criteria:
  • Patients with bleeding disorders or coagulopathies.
  • Patients on anti-coagulants.
  • Hypertensive patients whose systolic blood pressure (SBP) exceeds 160 mmHg.8.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Dr Smit Parmar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Smit Parmar

AIIMS RAIPUR

研究点 (1)

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