Secondary wound infection
Conditions
Interventions
experimental group:Antibacterial peptide PL-5 spray, with a dose of 2 ‰
active control:SulfamSilver Cream (1%)
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (including critical); 2. Has open wounds for secondary infections such as burns, abrasions, scratches, laceration, stitched wounds, traumatic ulcers, pressure ulcers, venous ulcer infections or diabetic foot ulcers with Wagner grade grade 2, and meets the following conditions: (1) The wound length of scratch, tear or suture shall not exceed 10 cm, around the single side of the erythema shall not exceed 2 cm; burns, abrasions, ulcers, pressure sores and other wound area shall not be less than 4 cm^2; (2) Clinical symptoms of wound infection meet the following conditions: Skin Infection Level Scale score (SIRS) (Appendix i) >= 8 points; (3) Anticipated that no surgery was required during the study (except the day 1 of the ICF]) and required topical medication. 3. Was collected from bacteriological samples and tested positive (bacterial or inflammatory cells found by gram staining); 4. Male subjects or female subjects of childbearing age agreed to take effective and safe contraception during treatment and within one week of treatment: women without sterilization, anatomically and physiologically pregnant after and before menopause. menopause is defined as permanent menopause, considered menopause if women [usually aged 45] for 12 consecutive months of natural [spontaneous] menopause); 5. Agrees to comply with the prohibition and restriction requirements specified in the program, to understand and sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Who collected no bacterial culture samples before group entry; 2. Used systemic antimicrobial therapy with >= 24 hours within 72 hours before entry or had topical antibiotics for the wound of this trial. If the researchers judge that the infection can not be improved; 3. Only requires simple surgical treatment or active local care, such as boils, acne, folliculitis, pustules, etc.; 4. Has one of the following wound infections: (1) Anticipated during the study (on day 1 after the final ICF administration (except for microbiological efficacy evaluation and comprehensive efficacy evaluation]) that subjects should be combined with other systemic or topical antimicrobial therapy and non-subjects with systemic antimicrobial therapy; (2) The pilot surface infection is known or suspected to be caused by non-bacterial pathogens such as fungi, parasites, chlamydia, mycoplasma or viruses; (3) Life-threatening infections or infections requiring emergency surgery, such as necrotizing fasciitis; (4) Has inflammatory skin diseases, such as atopic dermatitis or eczema, such as atopic dermatitis; (5) Pilot surface with artificial materials that cannot be removed, such as central venous catheter, battery pack of permanent pacemaker; (6) The Wagner classification (Appendix ii) is a diabetic foot ulcer of 0~1,3 and above; (7) Gangrene from any cause. 5. Is allergic to any component of the research drug (including antibacterial peptide PL-5 sprays and sulfonymine silver cream), or to sulfamines or silver salts, or to proteins, polypeptides; 6. pregnant or lactating women. It may be included if the lactating subjects agrees to stop breastfeeding during and within one week after the final medication; Excwith the following inspection results during the 7. screening period: Upper limit of ? total bilirubin & gt;3 times normal, or glutamate transaminase [ALT] or glutaminal transaminase [AST]?5 times the normal upper limit [ULN]; (1) Serum creatinine [Scr]>3 limit or any form of dialysis; (2) Neutroenia (Absolute Neutrotrophil Count [ANC]?1.0 x 10^9 / L) or Platelet Count & lt;50 x 10^9 / L; (3) QTC Interval Exception (QTc >= 500 msec) (calculated based on the Fridericia formula, see Appendix iii). 8. Patients with immunodeficiency, such as congenital immunodeficiency, people undergoing immunosuppressor therapy, or human immunodeficiency virus (HIV) positive patients; People who were using tumor chemotherapy drugs during 9. screening; 10. Persons with mental disorders or epilepsy; 11. Those who have participated in the clinical trial of the drug or device within 3 months prior to the first administration; 12. Any situation considered by the investigator that may increase the subject risk or affect the efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficiency on the first day after the final administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy on day 5 after administration;Bacteria clearance on day 5 after administration;Bacteria clearance on Day 1 after last administration;Comprehensive efficacy of Day 1 after the last administration;Comprehensive efficacy of Day 5 after administration; | — |
Countries
China
Contacts
Public ContactWu Jun
Shenzhen Second People's Hospital
Outcome results
None listed