Surgery Clinical Trial
Official title:
Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
Verified date | June 2016 |
Source | Bactiguard AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult men and women = 18 years of age - Were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial - Requiring CVC catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days - Had signed the informed consent Exclusion Criteria: - Known transmissive blood disease - Known multiresistant bacterial colonization - Ongoing infection - Thromboembolism - Anti-coagulation treatment excluding prophylaxis - CVC during last 2 months - History of problems with CVC - Pregnancy |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden | Stockholm | Huddinge |
Lead Sponsor | Collaborator |
---|---|
Bactiguard AB | Karolinska University Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course. | Overall assessment of safety by evaluation of CVC related adverse events and any problems in post operative course. | Through study completion, an average of 10 days | Yes |
Secondary | Assessment of the overall performance | Overall assessment of device performance by evaluation of any CVC handling problems experienced by the physician/health care personnel. | Through study completion, an average of 10 days | No |
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