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

Tri-Service General Hospital

Status: Completed

Conditions: Hemostasis

Treatments: Device: Chitosan Gauze; Device: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03907111

Hemostatic-Chitosan-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Chitosan gauze

Experimental group

Description:

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

Treatment:

Device: Chitosan Gauze

Traditional gauze

Placebo Comparator group

Description:

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

Treatment:

Device: placebo