Chronic wound with secondary infections
Conditions
Interventions
Experimental Group:For Experimental Group, Prontosan Wound Irrigation Solution is extracted with syringe (Dosage 1-2ml/cm2), and the wound is rinsed 1 cm from the wound. Then, Prontosan wound irrigati
Control Group:For Control Group, Normal Saline is extracted with syringe (Dosage 1-2ml/cm2), and the wound is rinsed 1 cm from the wound. Then, Normal Saline is used to saturate the gauze, and the gau
Sponsors
Department of Burn and Skin Wound Repair Surgery, First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. =18 years old; 3. Patients with chronic wound, eg. burns, and pressure injuries with stage 3 and 4. Diabetes foot ulcer with Wagner grade 2; (Staging and Wagner grading of stress injury can be found in attachments 1 and 2); 4. The length and width of a single wound in the wound area where the sampling point is located must be =2 cm, and the maximum length and width must be =10 cm; 5. The rapid smear test results of bacteria on the wound were positive; 6. The clinical symptoms of wound infection meet the following conditions: skin infection level scale score (SIRS) = 8; 7. Patients identified by the investigator as having biofilm formation on the wound; 8. No eschar covering the wound surface.
Exclusion criteria
Exclusion criteria: 1. Patients administered with systemic antibiotics 48 hours before enrollment; 2. Patients with severe autoimmune diseases; 3. Patients with pressure injuries classified as Stage I and II; (Please refer to Attachment 1 for for pressure injury staging); 4. Diabetes foot ulcer with Wagner grade0- 1 and more than 3; (Wagner grading of stress injury can be found in attachments 2); 5. Female in pregnancy or lactation period; 6. Those who have participated in clinical trials of drugs or devices within one month before the first treatment; 7. Patients who are allergic to any component of the research device; 8. Those who are currently using tumor chemotherapy drugs during screening; 9. Any condition that, in the opinion of the investigator, may increase the risk to the subjects or otherwise affect the evaluation of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in scoring the positive rate of bacterial biofilm before the first treatment and on the 7th day of treatment in Group A and Group B ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in scoring the positive rate of bacterial biofilm before the first treatment and on the 3rd day of treatment in Group A and Group B . ;Positive detection rate of bacterial biofilm in group A, group B and group C before the first treatment, and on the 3rd and 7th day of treatment, and difference of the positive detection rate of biofilm among the two groups;;4-phase typing of bacterial biofilm detected in Group A, Group B and Group C before the first treatment, and on the 3rd and 7th day of treatment, and the proportion difference of 4-phase typing of biofilm among the two groups;Wound healing rate;Skin Infection Rating Scale (SIRS) score;Distribution of inflammatory cells on the wound;Detection rate of bacteria/drug-resistant bacteria on the wound and their correlation with the detection rate of bacterial biofilm; | — |
Countries
China
Contacts
Public ContactJia'ao Yu
Department of Burn and Skin Wound Repair Surgery, First Hospital of Jilin University
Outcome results
None listed