Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT05924867
Eligibility Criteria:
1. Inclusion Criteria
1. Group of postoperative incision infection
* Age ≥18 years old, ≤75 years old, gender unlimited.
* Clinical diagnosis of postoperative incision infection.
* Must be no significant risk of head trauma or closed injury to the chest and abdomen.
* Fully understand the study content and subjects' rights and interests, and sign the informed consent.
2. Group of postoperative incision fat liquefaction
* Age ≥18 years old, ≤75 years old, gender unlimited.
* Clinical diagnosis of postoperative incision fat liquefaction.
* Must be no incision infection or organ infection was involved in deep surgery, and no other serious complications occurred.
* Must be no significant risk of head trauma or closed injury to the chest and abdomen.
* Fully understand the study content and subjects' rights and interests, and sign the informed consent.
3. Group of infectious ulcers
* Age ≥18 years old, ≤75 years old, gender unlimited.
* Clinical diagnosis of superficial skin ulcer infection caused by various causes, which can have one or more wounds.
* The formation time of the wound surface exceeds 1 month.
* Fully understand the study content and subjects' rights and interests, and sign the informed consent.
2. Exclusion Criteria
* Allergic to multiple drugs, dressings, gels or materials used in this study.
* Functional injury of cardiopulmonary system, with obvious risk of craniocerebral trauma or severe closed injury of chest and abdomen.
* Severe malnutrition, hypoproteinemia, moderate to severe anemia.
* Pregnant or lactating women (lactating female subjects can still be included if they agree to stop breastfeeding during the treatment period and within one week after the last medication).
* Patients with active wound bleeding, poor mental condition and critical condition.
* Poor glycemic control of diabetes mellitus; Severe malnutrition, hypoproteinemia, moderate and severe anemia.
* The presence of inflammatory skin diseases, such as atopic dermatitis or eczema, that affect efficacy and safety evaluation.
* Poor glycemic control of diabetes mellitus; Severe malnutrition, severe cardiopulmonary disease, hypertension, widespread local necrosis requiring immediate toe amputation.
* Combined with anaerobic bacteria infection, wet gangrene, abdominal infection, hematogenous infection, and intra-articular infection.
* Ulcers caused by diabetic feet and malignant tumors.
* History of glucocorticoid use and anticoagulant drug use within 12 months before enrollment.
* History of immune disease or immunosuppressant use.
* Poor compliance due to cognitive impairment or mental illness.
* Any conditions that the investigator considered might increase the risk to the subject or affect the evaluation of efficacy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05924867
Study Brief:
Protocol Section:
NCT05924867