Irrigation SolutionNCT06185465
Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm
A study testing Prontosan Wound Irrigation Solution and Normal Saline in people with Irrigation Solution and Chronic Wound, run by The First Hospital of Jilin University at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irrigation Solution, Chronic Wound, Pressure Injury
- What is being tested?
- Prontosan Wound Irrigation Solution and Normal Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- 3 Jan 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
Xinxin Gao, Ph.D, +86 13804337395, gaoxx2016@jlu.edu.cn
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Chenjian Zhong, Ph.D
Xintian Zhang
- Not yet recruiting
Shenzhen Second People's Hospital
Shenzhen, Shenzhen
Yating Wei, Ph.D
Rong Zhong
About this study
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.
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
- Being tested
- Prontosan Wound Irrigation Solution, Normal Saline
- Keywords
- Prontosan wound irrigation solution, Prontosan, Chronic wound, Pressure Injury, Burns, Diabetic Foot Ulcer
- Medical subject headings
- Pressure Ulcer, Diabetic Foot, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prontosan Wound Irrigation SolutionDevice
Also called Debridement surgery
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 SalineDevice
Also called Debridement surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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 (-).
Measured: 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.
Measured: 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.
Measured: Day0, Day3,Day7
Skin Infection Rating Scale (SIRS) score
- 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.
Measured: 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.
Measured: 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.
Measured: Day0, Day3,Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start3 Jan 2024
- Primary completion21 Feb 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irrigation SolutionStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Fujian Medical University Union Hospital
- Responsible party
- Sponsor
- Investigators
- Jia'ao Yu, Professor, Study chair, The First Hospital of Jilin UniversityJun Wu, Professor, Principal investigator, Shenzhen Second People's HospitalZhaohong Chen, Professor, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185465
- Sponsor's protocol ID
- 2023-075
- Status last verified
- Feb 2024
- First submitted
- 21 Nov 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not share.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06185465
- Acronym / sponsor ID
- 2023-075
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Fujian Medical University Union Hospital
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 21 Feb 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prontosan Wound Irrigation Solution rinse | Experimental | Device: Prontosan Wound Irrigation SolutionThe 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 | Active comparator | Device: Normal SalineFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prontosan Wound Irrigation SolutionAlso: Debridement surgeryAfter 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 | Prontosan Wound Irrigation Solution rinse |
| Normal SalineAlso: Debridement surgeryAfter 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. | Device | Normal Saline rinse |
Primary outcome
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
Time frame: Day0, Day7
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.
7 secondary outcomes
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
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
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
Time frame: Day0, Day3,Day7
Wound healing rate
Time frame: Day0, Day3,Day7
Skin Infection Rating Scale (SIRS) score
Time frame: Day0, Day3,Day7
Distribution of inflammatory cells on the wound
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
Time frame: Day0, Day3,Day7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No. Not share.
Related trials for Irrigation Solution
Recruiting
Clinical Efficacy of a Natural Biopolymer-Based Irrigant
Postoperative Pain
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruitingObservational study
Irrigation Fluid Volume, Tube Cuff Pressure, and Neck Swelling During Shoulder Arthroscopy
Shoulder Arthroscopy, Endotracheal Tube Cuff Pressure
Not yet recruiting
Effects of Irrigation Solutions at Different Temperatures Used in Mandibular Third Molar Surgery
Third Molars Extraction, Oral Health-Related Quality of Life
Not yet recruiting
Comparing Amla (Emblica Officinalis) and 3% Sodium Hypochlorite Against Enterococcus Faecalis in Root Canal Treatment.
Pulp Necrosis, Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia'ao Yu, Professor study chair
The First Hospital of Jilin University
Jun Wu, Professor principal investigator
Shenzhen Second People's Hospital
Zhaohong Chen, Professor principal investigator
Fujian Medical University Union Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prontosan Wound Irrigation Solution and Normal Saline in people with Irrigation Solution and Chronic Wound, run by The First Hospital of Jilin University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia'ao Yu, Professor (+86 13804337395, yuja@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day0, Day7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.