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

Not Applicable

Completed

• Conditions: Hemostasis
• Interventions: Device: Chitosan Gauze; Device: placebo

• Registration Number: NCT03907111
• Lead Sponsor: Tri-Service General Hospital

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.

Study Timeline

• Study Start: 2015-10-02
• Primary Completion: 2015-12-31
• Study Completion: 2016-02-10
• Status Verified: 2019-04
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-05
• Study First Posted: 2019-04-08
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chitosan gauze	Chitosan Gauze	100cm\^2 Gauze made by chitosan material. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care.
Traditional gauze	placebo	100cm\^2 Gauze made by traditional cotton yarn. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care.

Primary Outcome Measures

Name	Time	Method
Time to Hemostasis	one hour after the surgery	How many second it takes to stop bleeding

Secondary Outcome Measures

Name	Time	Method
Breeding volume	one hour after the surgery	the weight gain of the gauze from it been administrated on the wound until the hemostasis of the wound.
Relative light units difference	day0, day7 and day 14.	compare the relative light unit(RLU, relative light units, is by detecting the ATP concentration in the samples to determine the relative bacteria number, kikkoman PD-30) difference on the gauze collected at the daily wound care between chitosan gauze and traditional gauze.
size of the wound in millimeter	day1, day3, day 5, day7 and day14.	observe the difference of size between different treatment.