Develop the First Aid Medical Supplies for Hemostasis and Bacteriostasis With Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EGF-loaded Chitosan to Facilitate Healing and Prevent Scar Formation of Cesarean Wound

NCT04211597

Cesarean Wound Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn

COMPLETED NA

EFFECTİVİTY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

NCT06998641

Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum Tears Comparison of the Effect of Chitosan Covered Gauze With Suturing in Terms of Hemostasis in Post-partum Haemorrhagic Tears

RECRUITING NA

The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.

NCT06715696

Wounds and Injuries Hemostasis

COMPLETED NA

Adhesive Tape in Episiotomy Repair

NCT02608671

Episiotomy

COMPLETED PHASE4

Cesarean Wound Closure: Dermabond Versus Steri Strips

NCT04621994

Scar

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Each of the participants is treated with 2 different treatments on different areas of the same wound at the same time.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Regular Gauze Treatment

Participants who undergo a cesarean section are first dissected in about 5 cm length and 2 cm width and receive a regular gauze made of traditional cotton yarn. The regular gauze is applied on the half side of the wound.

Group Type PLACEBO_COMPARATOR

Regular Gauze

Intervention Type DEVICE

Regular gauze

Chitosan Dressing Treatment

Participants who undergo a cesarean section are first dissected in about 5 cm length and 2 cm width and receive a chitosan dressing made of chitosan material. The chitosan dressing is applied on another half side of the wound.

Group Type EXPERIMENTAL

Chitosan Dressing

Intervention Type DEVICE

Dressing made of chitosan material

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Regular Gauze

Regular gauze

Intervention Type DEVICE

Chitosan Dressing

Dressing made of chitosan material

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No