Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm

NCT06185465 | Recruiting

• 1 other identifier: 2023-075
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Prontosan wound irrigation solution; Prontosan; Chronic wound; Pressure Injury; Burns; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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=the total score of 3 tissues before treatment- the total score of 3 tissues treatment after 7days. To compare the score difference between 2 groups after the difference is calculated.

  Day0, Day7

Secondary Outcomes (7)

• 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

  Day0, Day3

• 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

  Day0, Day3,Day7

• 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

  Day0, Day3,Day7

• Wound healing rate

  Day0, Day3,Day7

• Skin Infection Rating Scale (SIRS) score

  Day0, Day3,Day7

Study Arms (2)

Prontosan Wound Irrigation Solution rinse

EXPERIMENTAL

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.

Device: Prontosan Wound Irrigation Solution

Normal Saline rinse

ACTIVE COMPARATOR

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.

Device: Normal Saline

Interventions

Prontosan Wound Irrigation Solution 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.

Also known as: Debridement surgery

Prontosan Wound Irrigation Solution rinse

Normal Saline 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.

Also known as: Debridement surgery

Normal Saline rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily sign the informed consent form;
• \. ≥18 years old;
• \. 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);
• \. 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;
• \. The rapid smear test results of bacteria on the wound were positive;
• \. The clinical symptoms of wound infection meet the following conditions: skin infection level scale score (SIRS) ≥ 8;
• \. Patients identified by the investigator as having biofilm formation on the wound;
• \. No eschar covering the wound surface.

You may not qualify if:

• \. Patients administered with systemic antibiotics 48 hours before enrollment;
• \. Patients with severe autoimmune diseases;
• \. Patients with pressure injuries classified as Stage I and II; (Please refer to Attachment 1 for for pressure injury staging);
• \. Diabetes foot ulcer with Wagner grade0- 1 and more than 3; (Wagner grading of stress injury can be found in attachments 2);
• \. Female in pregnancy or lactation period;
• \. Those who have participated in clinical trials of drugs or devices within one month before the first treatment;
• \. Patients who are allergic to any component of the research device;
• \. Those who are currently using tumor chemotherapy drugs during screening;
• \. Any condition that, in the opinion of the investigator, may increase the risk to the subjects or otherwise affect the evaluation of efficacy.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• Shenzhen Second People's Hospital: collaborator
• Fujian Medical University Union Hospital: collaborator

Study Sites (3)

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

MeSH Terms

Conditions

Pressure Ulcer; Diabetic Foot; Burns

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Wounds and Injuries

Study Officials

• Jia'ao Yu, Professor

  The First Hospital of Jilin University

  STUDY CHAIR

• Jun Wu, Professor

  Shenzhen Second People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhaohong Chen, Professor

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia'ao Yu, Professor

CONTACT

+86 13804337395; yuja@jlu.edu.cn

Xinxin Gao, Ph.D.

CONTACT

+86 13804337395; gaoxx2016@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 29, 2023
• Study Start: January 3, 2024
• Primary Completion: February 21, 2024
• Study Completion: February 28, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)