CompletedPhase 4

BIP CVC Clinical Safety and Performance Study

Sweden36 participantsStarted 2013-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.

Timeframe: Through study completion, an average of 10 days

Trial details

NCT IDNCT02811380

SponsorBactiguard AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

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