Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm

NCT ID: NCT06185465

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2025-02-28

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.

Conditions

Irrigation Solution; Chronic Wound; Pressure Injury; Diabetic Foot Ulcer; Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prontosan Wound Irrigation Solution rinse

The test group is selected according to the randomization number of enrollment. 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 irrigation solution 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.

Group Type: EXPERIMENTAL

Prontosan Wound Irrigation Solution

Intervention Type: DEVICE

After debridement surgery, the test group is selected according to the randomization number of enrollment. 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 irrigation solution 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.

Normal Saline rinse

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 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.

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: DEVICE

After debridement surgery, the test group is selected according to the randomization number of enrollment. 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 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.

Interventions

Prontosan Wound Irrigation Solution

After debridement surgery, the test group is selected according to the randomization number of enrollment. 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 irrigation solution 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.

Intervention Type: DEVICE

Normal Saline

After debridement surgery, the test group is selected according to the randomization number of enrollment. 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 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.

Intervention Type: DEVICE

Other Intervention Names

Debridement surgery; Debridement surgery

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia'ao Yu, Professor

Role: STUDY_CHAIR

The First Hospital of Jilin University

Jun Wu, Professor

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Second People's Hospital

Zhaohong Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: NOT_YET_RECRUITING

First Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Shenzhen, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Jia'ao Yu, Professor

Role: CONTACT

yuja@jlu.edu.cn

+86 13804337395

Xinxin Gao, Ph.D.

Role: CONTACT

gaoxx2016@jlu.edu.cn

+86 13804337395

Facility Contacts

Chenjian Zhong, Ph.D

Role: primary

Xintian Zhang

Role: backup

Xinxin Gao, Ph.D

Role: primary

gaoxx2016@jlu.edu.cn

+86 13804337395

Yating Wei, Ph.D

Role: primary

Rong Zhong

Role: backup

Other Identifiers

2023-075

Identifier Type: -

Identifier Source: org_study_id