Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185465
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-11-21
Brief Title:
Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bacteriadrug-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 1-2mlcm2 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
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 bacteriadrug-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 1-2mlcm2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None