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The decision to terminate this clinical study was made as a cost control measure.
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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This is a single-center, prospective, randomized controlled clinical trial designed to compare the antimicrobial efficacy of Tegaderm CHG I.V. Securement Dressing and transparent dressings for deep vein catheterization in adult ICU patients.
This clinical trial is designed as a prospective, randomized, open-label, parallel-group controlled trial.
Investigational product: 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing Control product: 3MTM TegadermTM Transparent Film Dressing 1626W
Considering the easy-to-distinguish appearances of both products used, this trial will adopt an open-label design. The primary endpoint is the rate of CVC tip colonization (positive catheters after culture/total catheters).
Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
440 subjects who meet the inclusion/exclusion criteria will be enrolled. Subjects will be adult voluntary clinical subjects, of either sex, at least 18 years of age, who are ICU patients undergoing deep venous catheterization (DVC), in which a CVC catheter must be used while other types of catheters such as hemodialysis, PICCO, and floating catheters may be used concurrently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing | Experimental | The primary purpose of 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes. |
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| 3Mâ„¢ Tegadermâ„¢ Transparent Film Dressing 1626W | Active Comparator | Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing | Device | Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters) | Rate of CVC tip colonization (positive catheters after culture/total catheters) | 3-14 days |
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Inclusion Criteria:
Subjects may be included that meet the following criteria:
Exclusion Criteria:
Subjects may not be included that meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongping Qu | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | China |
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After 123 subjects were enrolled and completed all the visits, the study was terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3Mâ„¢ Tegadermâ„¢ Transparent Film Dressing 1626W | Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China. 3Mâ„¢ Tegadermâ„¢ Transparent Film Dressing 1626W: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2021 | Jun 5, 2023 |
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| 3Mâ„¢ Tegadermâ„¢ Transparent Film Dressing 1626W | Device | Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU. |
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| FG001 | 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing | The primary purpose of 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes. 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing | The primary purpose of 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes. 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU. |
| BG001 | 3Mâ„¢ Tegadermâ„¢ Transparent Film Dressing 1626W | Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China. 3Mâ„¢ Tegadermâ„¢ Transparent Film Dressing 1626W: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters) | Rate of CVC tip colonization (positive catheters after culture/total catheters) | This endpoint was not collected for all subjects randomized. Also, the study had major protocol deviations that made the available data unreliable. | Posted | 3-14 days |
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3-14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3Mâ„¢ Tegadermâ„¢ Transparent Film Dressing 1626W | Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China. 3Mâ„¢ Tegadermâ„¢ Transparent Film Dressing 1626W: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU. | 2 | 62 | 2 | 62 | 44 | 62 |
| EG001 | 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing | The primary purpose of 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes. 3Mâ„¢ Tegadermâ„¢ CHG I.V. Securement Dressing: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU. | 0 | 61 | 0 | 61 | 46 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Circulatory collapse | Vascular disorders | Systematic Assessment |
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| Intraventricular hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart rate increased | Investigations | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Hypoproteinaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Amylase increased | Investigations | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Delirium | Psychiatric disorders | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| White blood cell count increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood pressure increased | Investigations | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sputum increased | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Incision site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision site discharge | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hongping Qu | Ruijin Hospital | 021-64370045 | rjhcrc@126.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2020 | Jun 5, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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