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Clinical Trials/NCT06457360
NCT06457360
Completed
Early Phase 1

Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following Dental Extraction in Liver Pre-Transplant Children

British University In Egypt1 site in 1 country39 target enrollmentNovember 15, 2023

Overview

Phase
Early Phase 1
Intervention
Chitosan
Conditions
Liver Cirrhosis
Sponsor
British University In Egypt
Enrollment
39
Locations
1
Primary Endpoint
To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of the present study is:

To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases where the:

• Primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent

Registry
clinicaltrials.gov
Start Date
November 15, 2023
End Date
May 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with end stage liver disease that need dental extraction before liver transplant
  • Patients aged between 4 and 9 years old
  • Patients having international normalized ratio (INR) values ≤ 4 (i.e. 1-4)

Exclusion Criteria

  • Patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell.
  • Patients having genetic bleeding disorders
  • Patients with renal diseases

Arms & Interventions

group 1 sterile gauze with chitosan

Chitosan-based dressing gauze after extraction in patients with end stage liver disease

Intervention: Chitosan

group 2 sterile gauze with ankaferd blood stopper

ankaferd blood stopper dressing gauze after extraction in patients with end stage liver disease

Intervention: Ankaferd Blood Stopper

group 3 sterile gauze with tranexamic acid

tranexamic acid dressing gauze after extraction in patients with end stage liver disease

Intervention: tranexamic acid

Outcomes

Primary Outcomes

To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases

Time Frame: 30 minutes

evaluation of the previous materials which will be the most effective as a hemostatic agent by measuring blood loss after dental extraction after 30 minutes by the weight difference between the gauze preoperatively and postoperatively using fine electronic measurement weight device

Secondary Outcomes

  • pain score assessment(7 days)

Study Sites (1)

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