Hemostasis
Conditions
Keywords
bleeding wounds, hemostasis, open wounds, infection, antimicrobial
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.
Interventions
DEVICEChitosan Gauze
Gauze made by chitosan material
DEVICEplacebo
traditional gauze
Sponsors
National Defense Medical Center, Taiwan
Tri-Service General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | one hour after the surgery | How many second it takes to stop bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed