Clinical trial NCT06185465: Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm
Official title: Effectiveness and Safety of Using Prontosan Wound Irrigation Solution to Treat Bacterial Biofilm in Chronic Wound Patients With Secondary Infections: a Randomized, Controlled, Open Multicenter Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irrigation Solution
Chronic Wound
Pressure Injury
Diabetic Foot Ulcer
Burns
Keywords: Prontosan wound irrigation solution
Prontosan
Chronic wound
Pressure Injury
Burns
Diabetic Foot Ulcer
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: Shenzhen Second People's Hospital
name: Fujian Medical University Union Hospital
First posted: 2023-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Normal Saline on the removal of wound bacterial biofilm through observing the morphological characteristics and development of bacterial biofilm in chronic wound patients with secondary infections. The main questions it aims to answer are:

* 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
* 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 and group B 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.

Participants will be randomized to experimental group or Control group, Prontosan Wound Irrigation Solution or normal saline will be extracted with syringe (Dosage 1-2ml/cm2), and the wound is rinsed 1 cm from the wound. Then, Prontosan wound irrigation solution or normal saline is used to saturate the gauze, and the gauze is applied to the wound for 15 minutes. After removing the gauze, cover it with oil gauze, then cover it with 8 layers of gauze and wrap it with a bandage.


Eligibility 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:

* 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.

Primary outcomes:
measure: 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
timeFrame: Day0, Day7
Secondary outcomes:
measure: 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
timeFrame: Day0, Day3
measure: Positive detection rate of bacterial biofilm in group and group B 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
timeFrame: Day0, Day3,Day7
measure: 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
timeFrame: Day0, Day3,Day7
measure: Wound healing rate
timeFrame: Day0, Day3,Day7
measure: Skin Infection Rating Scale (SIRS) score
timeFrame: Day0, Day3,Day7
measure: Distribution of inflammatory cells on the wound
timeFrame: Day0, Day3,Day7
measure: Detection rate of bacteria/drug-resistant bacteria on the wound and their correlation with the detection rate of bacterial biofilm
timeFrame: Day0, Day3,Day7
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Shenzhen
Study officials:
affiliation: The First Hospital of Jilin University
name: Jia'ao Yu, Professor
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Jun Wu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Medical University Union Hospital
name: Zhaohong Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: