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临床试验 NCT06185465 针对Irrigation Solution，慢性伤口，压力性损伤，糖尿病足溃疡，烧伤目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm
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临床试验NCT06185465是一项针对Irrigation Solution，慢性伤口，压力性损伤，糖尿病足溃疡，烧伤的干预性研究试验，目前试验状态为招募中。试验始于2024年1月3日，计划招募60名患者。该研究由The First Hospital of Jilin University主导，预计于2025年2月28日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年2月23日。
简要概括
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.
官方标题
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.
疾病
Irrigation Solution慢性伤口压力性损伤糖尿病足溃疡烧伤其他研究标识符
- 2023-075
NCT编号
实际开始日期
2024-01-03
最近更新发布
2024-02-23
预计完成日期
2025-02-28
计划入组人数
60
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Prontosan wound irrigation solution
Prontosan
Chronic wound
Pressure Injury
Burns
Diabetic Foot Ulcer
Prontosan
Chronic wound
Pressure Injury
Burns
Diabetic Foot Ulcer
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Prontosan Wound Irrigation Solution rinse 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. | 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. |
阳性对照Normal Saline rinse 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. | 生理盐水 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. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 | 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 (-). | 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. | 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. | 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. | 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. | 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. | Day0, Day3,Day7 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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.
- 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;
- 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.
The First Hospital of Jilin University- Shenzhen Second People's Hospital
- 福建医科大学309 个活跃的临床试验可供探索
研究中心联系人
联系人: Jia'ao Yu, Professor, +86 13804337395, [email protected]
联系人: Xinxin Gao, Ph.D., +86 13804337395, [email protected]
3 位于 1 个国家/地区的研究中心
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Chenjian Zhong, Ph.D, 联系人
Xintian Zhang, 联系人
尚未招募
Jilin
First Hospital of Jilin University, Changchun, Jilin, China
Xinxin Gao, Ph.D, 联系人, +86 13804337395, [email protected]
招募中
Shenzhen
Shenzhen Second People's Hospital, Shenzhen, Shenzhen, China
Yating Wei, Ph.D, 联系人
Rong Zhong, 联系人
尚未招募