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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Develop the Biologic-fibrotic Dressing on War Open Bleeding Wounds for Hemostasis.

Conditions
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Hemostasis

Intervention / Treatment
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* Device: Chitosan Gauze
* Device: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each of the participants was been treated with 2 different treatments on different areas of the same wound at the same time.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chitosan gauze<br>100cm^2 Gauze made by chitosan material. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care. | Device: Chitosan Gauze<br>* Gauze made by chitosan material<br>|
| Placebo Comparator: Traditional gauze<br>100cm^2 Gauze made by traditional cotton yarn. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care. | Device: placebo<br>* traditional gauze<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis | How many second it takes to stop bleeding | one hour after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breeding volume | the weight gain of the gauze from it been administrated on the wound until the hemostasis of the wound. | one hour after the surgery | 
| Relative light units difference | 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. | day0, day7 and day 14. | 
| size of the wound in millimeter | observe the difference of size between different treatment. | day1, day3, day 5, day7 and day14. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bleeding wounds, hemostasis, open wounds, infection, antimicrobial