Using Prontosan to treat bacterial biofilm in chronic wounds

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.

This study is testing if Prontosan, a special wound cleaning solution, can better remove harmful bacteria from chronic wounds like diabetic foot ulcers compared to regular salt water.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Fuzhou, Fujian and 2 other locations)
• Trial ID: NCT06185465 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Prontosan wound irrigation solution compared to Normal Saline in removing bacterial biofilm in patients with chronic wounds, such as diabetic foot ulcers and pressure injuries. It is a prospective, multi-center, randomized, parallel-controlled, open-label study that aims to measure the positive detection rate of bacterial biofilm before and after treatment. The study will assess the morphological characteristics of the biofilm and its development over time in response to the treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic wounds, such as burns or diabetic foot ulcers, that show signs of bacterial infection and biofilm formation.

Not a fit: Patients with early-stage pressure injuries or those who have received systemic antibiotics within 48 hours prior to enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients with chronic wounds affected by bacterial biofilm.

How similar studies have performed: Other studies have shown promising results using similar approaches to treat bacterial biofilm in chronic wounds, indicating potential for success.

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.

Where this trial is running

Fuzhou, Fujian and 2 other locations

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Shenzhen Second People's Hospital — Shenzhen, Shenzhen, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Jun Wu, Professor — Shenzhen Second People's Hospital
• Study coordinator: Jia'ao Yu, Professor

Conditions Irrigation Solution; Chronic Wound; Pressure Injury; Diabetic Foot Ulcer; Burns; Prontosan wound irrigation solution; Prontosan; Chronic wound