Status:
RECRUITING
Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm
Lead Sponsor:
The First Hospital of Jilin University
Collaborating Sponsors:
Shenzhen Second People's Hospital
Fujian Medical University Union Hospital
Conditions:
Irrigation Solution
Chronic Wound
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this prospective, multi-center, randomized, parallel-controlled, open-label clinical study is to evaluate the effectiveness and safety of Prontosan wound irrigation solution comparing with...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06185465
Start Date
January 3 2024
End Date
February 28 2025
Last Update
February 23 2024
Active Locations (3)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
2
First Hospital of Jilin University
Changchun, Jilin, China
3
Shenzhen Second People's Hospital
Shenzhen, Shenzhen, China