Clinical trial NCT03907111: Compare the Hemostatic Effectiveness of Chitosan Gauze With Traditional Gauze on Open Wound on 10 Participants.
Official title: Develop the Biologic-fibrotic Dressing on War Open Bleeding Wounds for Hemostasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemostasis
Keywords: bleeding wounds, hemostasis, open wounds, infection, antimicrobial
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
Collaborators: name: National Defense Medical Center, Taiwan
First posted: 2019-04-08
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each of the participants was been treated with 2 different treatments on different areas of the same wound at the same time.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to Hemostasis
timeFrame: one hour after the surgery
Secondary outcomes:
measure: Breeding volume
timeFrame: one hour after the surgery
measure: Relative light units difference
timeFrame: day0, day7 and day 14.
measure: size of the wound in millimeter
timeFrame: day1, day3, day 5, day7 and day14.
Other outcomes:
Locations:
Study officials:
References:
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