Compare the Hemostatic Effectiveness of Chitosan Gauze With Traditional Gauze on Open Wound on 10 Participants.

NCT ID: NCT03907111

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-02
• Study Completion Date: 2016-02-10

Brief Summary

This study recruited 10 subject participants to compare the hemostasis gauze made by chitosan with traditional cotton gauze to see which one is better in bleeding time, bleeding volume, wound infection and wound healing speed when it is used in open wound treatment.

Detailed Description

open wound bleeding and infection care policy development is focusing on efficiency to strengthen internal bleeding, pain, avoidance of infection and promoting wound healing wound. With the changes in the social environment, people caring for hemostasis and wound healing have become increasingly demanding. Presently, studies generally aim to stop the bleeding using trauma care technology and functional capabilities combined with each other as well as inhibit lower infection and can also help assist healing wounds care strategy for the protection of human lives. Therefore, the goal of the plan is to establish new care strategies on open wounds infection to stop the bleeding and to improve the health and safety of the people. The researchers will choose the general biological hemostatic gauze to conduct clinical trials comparing the clinical hemostasis focusing on bleeding time, wound infection in the wound and the wound bacteria penetrating situations in the hope to build a better strategy in rapid hemostasis and wound infection care strategy.

Conditions

Hemostasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chitosan gauze

100cm\^2 Gauze made by chitosan material. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care.

Group Type: EXPERIMENTAL

Chitosan Gauze

Intervention Type: DEVICE

Gauze made by chitosan material

Traditional gauze

100cm\^2 Gauze made by traditional cotton yarn. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DEVICE

traditional gauze

Interventions

Chitosan Gauze

Gauze made by chitosan material

Intervention Type: DEVICE

placebo

traditional gauze

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients need laparotomy, with the expected wound size bigger than 5 cm in length and 2 cm in width.

Exclusion Criteria

• Have history of allergy to shrimp, crab and other chitins.
• Patients with blood clotting disorders
• Vulnerable group
• Patients with unstable vital sign

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: collaborator

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsu Sheng-Der

attending physician, department of traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

Hemostatic-Chitosan-2015

Identifier Type: -

Identifier Source: org_study_id