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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGFirst Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGShenzhen Second People's Hospital
Shenzhen, Shenzhen, China
NOT_YET_RECRUITINGDifference 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.
Time frame: Day0, Day7
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
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 3 days. To compare the score difference between 2 groups after the difference is calculated
Time frame: 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
If any of the 3 samples is tested positive for the biofilm, the result will be judged positive (+); If no biofilm is detected in the 3 samples, the result will be judged negative (-).
Time frame: 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
Typing I: 0 point is scored in case of free bacteria, i.e., dispersed phase of monomer bacteria; Typing II: 0 points are scored in case of bacterial adhesion, i.e., aggregation phase of monomer bacteria; Typing III\&IV: 3 points are scored in case of mature bacterial biofilm, i.e., closed phase of colony bacteria; 3 points are scored in case of spreading of bacterial biofilm, i.e., open phase of colony bacteria.
Time frame: Day0, Day3,Day7
Wound healing rate
The wound is covered with sterile mesh film before the first treatment, and on the 3rd and 7th day of treatment, the wound area is measured and recorded, and the difference in wound healing rate among the two groups is compared.
Time frame: Day0, Day3,Day7
Skin Infection Rating Scale (SIRS) score
o Skin Infection Rating Scale (SIRS) scoring is conducted and recorded before the first treatment, and on the 3rd and 7th day of treatment to compare the differences of SIRS scores among the two groups. SIRS scoring Items include Exudate / pus, Scabbing, Erythema/Inflammation, Tissue edema, Tissue fever, Pruritus and Pain. The scores of every items are 0=none, 1=mild, 2= Moderate, 3= severe.
Time frame: Day0, Day3,Day7
Distribution of inflammatory cells on the wound
The H-E staining pathological sections of inflammatory cells on the wound are carried out before the first treatment, and on the 3rd and 7th day of treatment to compare the differences in the distribution type (Monocytes/Neutrophils/Lymphocytes) and quantity(No infiltration, mild infiltration, moderate infiltration, severe infiltration) of inflammatory cells on the wound among the two groups. mild infiltration refers to the infiltration of less than or equal to 10 inflammatory cells； moderate infiltration refers to the infiltration of 11-50 inflammatory cells; severe infiltration refers to the infiltration of more than 50 inflammatory cells.
Time frame: Day0, Day3,Day7
Detection rate of bacteria/drug-resistant bacteria on the wound and their correlation with the detection rate of bacterial biofilm
According to the test results, the number of bacteria positive cases and number of drug-resistant positive bacteria cases are counted, and the difference in anti-infection ability of the two groups after 3 and 7 days of wound treatment is compared by the number of positive cases/total number of burn patients in each group and the number of drug-resistant bacteria positive cases/total number of burn patients in each group.
Time frame: Day0, Day3,Day7
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