Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN93939200 | Registry Identifier | ISRCTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gambro Dialysatoren GmbH | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.
The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation.
In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.
Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections.
The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients in group A will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891). |
|
| B | Experimental | Patients in group B will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GamCath® central venous catheter | Device | choice of catheter type |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial colonisation of the catheter surface | at explantation |
| Measure | Description | Time Frame |
|---|---|---|
| Surface deposits of thrombogenic activity | at explantation | |
| Catheter survival | at explantation | |
| Exit site appearance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christiane M Erley, Prof. Dr. | St. Joseph-Krankenhaus Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph-Krankenhaus Berlin | Berlin | 12101 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38940297 | Derived | Schults JA, Kleidon T, Charles K, Young ER, Ullman AJ. Peripherally inserted central catheter design and material for reducing catheter failure and complications. Cochrane Database Syst Rev. 2024 Jun 28;6(6):CD013366. doi: 10.1002/14651858.CD013366.pub2. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GamCath Dolphin® Protect central venous catheter | Device | choice of catheter type |
|
|
| at routine catheter care |
| Blood parameters | during dialysis |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |