Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

• Shenzhen Second People's Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  lead OTHER

Principal Investigators

• Jia'ao Yu, Professor · The First Hospital of Jilin University

• Jun Wu, Professor · Shenzhen Second People's Hospital

• Zhaohong Chen, Professor · Fujian Medical University Union Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-03

Primary Completion

2024-02-21

Completion

2025-02-28

Countries

• China

Study Locations