Clinical trial NCT04884919: Develop the First Aid Medical Supplies for Hemostasis and Bacteriostasis With Clinical Trial
Official title: Develop the First Aid Medical Supplies for Hemostasis and Bacteriostasis With Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 40
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 is treated with 2 different treatments on different areas of the same wound at the same time.
Primary purpose: TREATMENT

Brief summary: The current development of hemostatic and open wound infection care strategies will focus on enhancing the efficiency of hemostasis for internal bleeding, relieving pain, avoiding wound infection, and promoting wound healing. As the social environment changes, the demand for hemostatic techniques and wound healing is increasing. Thus, hemostatic techniques are needed to be integrated with functional functions for usual trauma care, and the wound care strategies that can inhibit and reduce infection while helping to facilitate wound healing are needed to be developed to ensure the safety of human life. Therefore, this trial aims to develop new biofiber hemostatic dressings for hemostasis and open wound care. The comparisons of hemostatic and antibacterial effects, hemostatic time, wound infection status, wound bacteria count, and wound adhesion situation obtained from this clinical trial are expected able to establish a better rapid hemostatic strategy and wound infection care strategy.

Detailed description: This trial is performed when the subjects undergoing a cesarean section at Tri-Service General Hospital, Taipei, Taiwan (R.O.C). After disinfection of the surgical wound, regular gauze and chitosan dressings are directly and simultaneously placed over the disinfected wound with finger pressure for 3 min, immediately after the dissection. The regular gauze dressing is placed on half side of the surgical wound, while the chitosan dressing is placed on another half side of the wound. After 3 min, the pressure is stopped and the doctors will photograph and observe both dressings whether the bleeding has stopped. If the bleeding on the surface of the wound has stopped after 20 s, the bleeding is considered to have stopped and the wound is then treated according to the scheduled surgical procedure. If the bleeding has not stopped, finger pressure to stop bleeding will be given for 5 min. Then, after 5 minutes, the pressure is stopped and the bleeding condition is observed. If the bleeding has stopped after 20 s, the bleeding of the wound is judged to have stopped and the subsequent surgery will be performed. However, if it still bleeds, both dressings will be replaced and do the same for another 5 min. (Note) Depending on the physiological parameters of each patient, the decision can be determined by the physician; if bleeding or hematoma occurs, the patient will be treated according to hospital procedure until the symptoms are relieved, and evaluate whether the test should be stopped.

The postoperative wound will be dressed with regular gauze and chitosan dressings and the wound condition will be recorded on day 0 of the trial. The dressing is daily changed by replacing regular gauze and chitosan dressings and by performing wound care. The test of the dressing sample will be taken for bacterial analysis. If there are symptoms of infection after 14 days of this test, the wound will be treated in accordance with the clinical routine wound treatment. (Note) If the wound condition shows serious infection during the dressing change process, the treatment should be carried out according to the clinical routine treatment method, and it is determined and evaluated whether to stop the test. (Note) If the patient's psychological stress is affected during the trial, the physician will explain and determine whether the trial must be stopped.

Eligibility criteria: Inclusion Criteria:

* The subject is aged between 20 and 80 years old.
* Patients who need a cesarean section.
* The expected size of the wound is about 5 cm or more in length and 2 cm or more in width.

Exclusion Criteria:

* Patients with a history of allergy to chitin components such as shrimp and crab.
* Patients with blood clotting disorders.
* Vulnerable groups.
* Patients with unstable signs of life.

Primary outcomes:
measure: Hemoglobin Assay
timeFrame: 3 up to 13 minutes
measure: Adenosine Triphosphate (ATP) Assay
timeFrame: Up to 8 days
measure: Phylogenetic of Microbial Community
timeFrame: Up to 3 days
measure: Heat Map Analysis
timeFrame: Up to 6 days
measure: Partial Least Squares Discriminant Analysis (PLS-DA)
timeFrame: Up to 6 days
measure: UpSet Plot
timeFrame: Up to 6 days
measure: Statistical Analysis
timeFrame: Up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Defense of Medical Center, Tri-Service General Hospital
Study officials:
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