Secondary wound infection
Conditions
Interventions
Experimental group:Antibacterial peptide PL-5 topical spray, with a dose of 2 ‰
Control group:Antibacterial peptide PL-5 topical spray placebo, with a dose of 0
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years (including the critical value), gender is not limited. 2. Mild burn wounds with secondary infection during screening, and the following conditions are met: (1) 25 cm^2=2; (3) The total burned area is less than 10% of the total body surface area (TBSA) and does not require rehydration treatment; (4) It is expected that during the study period (from the signing of the informed consent [ICF] to the completion of the relevant evaluation of the trial on the first day after the end of the last dose (except the evaluation of microbiological efficacy and comprehensive efficacy), no surgery is required, but local treatment is required. 3. Bacteriological samples were collected and found to be positive by microscopy. 4. Male subjects or female subjects of reproductive age agree to use effective and safe contraceptive methods during treatment and for one week after the end of treatment (definition of women of reproductive age: women who have not been sterilized from menarche to menopause and are anatomically and physiologically capable of becoming pregnant). Menopause is defined as permanent menopause and is considered to be menopausal if a woman [usually over the age of 45] has stopped menses naturally [spontaneously] for 12 consecutive months). 5. Agree to comply with the prohibitions and restrictions set out in the program, understand and sign the ICF.
Exclusion criteria
Exclusion criteria: 1. No bacterial culture samples were collected before enrollment. 2. Patients who had been treated with systemic antibiotics within 72 hours before enrollment and the drug action time was >=24 hours, or had been treated with local antibiotics for the wounds tested in this study. Note: If the investigator determines that the treatment is not effective, it can still be included. 3. Patients with one of the following wound infections: (1) It is expected that during the study period (from the signing of ICF to the completion of the relevant evaluation of the trial on the first day after the end of the last administration (excluding the evaluation of microbial efficacy and comprehensive efficacy), the patient wound should be treated with other systemic or local antibiotics, and the non-patient wound should be treated with systemic antibiotics; (2) The infection of the tested wound is known or suspected to be caused by non-bacterial pathogenic microorganisms such as fungi, parasites, chlamydia, mycoplasma or viruses; (3) Life-threatening infections or infections requiring emergency surgery, such as necrotizing fasciitis, etc.; (4) There are inflammatory skin diseases that affect the evaluation of efficacy and safety, such as atopic dermatitis, eczema, psoriasis, or allergic reactions during screening; (5) The test wound has artificial materials that cannot be removed, such as central venous catheter, battery pack of permanent cardiac pacemaker, etc.; (6) Gangrene of any cause; (7) Patients with cellulitis or erysipelas. 4. Allergic to any component of the investigational drug (including the antimicrobial peptide PL-5 spray and placebo), or allergic to proteins or peptides. 5. Pregnant or lactating patients. Note: Lactating female patients can still be included if they agree to stop breastfeeding during treatment and within one week after the last dose. 6. Patients with abnormal test results during the screening period: (1) Total bilirubin >3 times the upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 5 times ULN; (2) Serum creatinine (Scr) >3 times ULN or any form of dialysis; (3) Neutropenia [absolute neutrophil count (ANC) 1.5×ULN), or white blood cell count >1.5×ULN or 2×ULN or platelet count = 500 msec) (calculated according to Fridericia's formula). 7. Clear fever during screening [e.g., core body temperature (tympanic membrane, rectum, esophagus) >=38?, oral temperature >=37.5? or axillary temperature >=37?], Other signs of systemic infection (including but not limited to increased or decreased white blood cell count (above or below the upper or lower limit of the reference value) or increased neutrophil percentage (above the upper limit of the reference value) in peripheral blood images; involvement of the lymphatic system (lymphangitis or lymph node enlargement in or near the lymph drainage area at the site of infection). 8. Patients with rheumatic immune diseases or immune deficiencies, such as congenital immune deficiency, patients who are receiving immunosuppressive therapy or patients who are HIV positive; 9. Severe cardiovascular, liver, kidney, or hematological diseases, or chronic diseases that researchers judge affect wound healing (including but not limited to diabetes, gout, rheumatoid arthritis, etc.). 10. Patients who are using tumor chemotherapy drugs at the time of screen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of wound healing on day 1 after the end of the last administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing rate ;Basal epithelialization index ;Microbial response rate;Adverse Events; | — |
Countries
China
Contacts
Public ContactWu Jun
Shenzhen Second People's Hospital
Outcome results
None listed