CHLOVEPI
Effect of 2% Alcoholic Chlorhexidine Compared to Povidone Iodine Solution to Limit Colonisation After Perineural Catheterization in Orthopaedic Surgery
Sponsor study identifier
interventional
92
1 country
1
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 15, 2018
Actual (reported)Study Completion
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Implementation of perineural catheters may lead to infection by catheter colonization. Catheters may be colonized by the bacteria present on the skin. This is most often commensal organisms as Staphylococcus or gram negative bacilli. In a large study of 1416 peripheral nerve catheters, 28.7% of catheters were cultured positive. This colonization is most often silent because in the same study only 3% of patients had signs of local inflammation and one psoas abscess was observed (0.07%). The germs are most often coagulase negative staphylococci (61%) and gram negative bacillus (21.6%).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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January 20, 2016
Actual (reported)November 2016
Date type not reportedThis date has not been verified as actual or estimated.
November 1, 2016
Actual (reported)July 15, 2018
Actual (reported)November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
perineural catheter colonization reduction
Assuming a frequency of the event without treatment 40%, to highlight a sub treatment relative reduction in frequency of 80% it is necessary to include 92 patients (for a 90% power and a alpha risk of 1%). According to the technique of Brun-Buisson, the catheter will be collected in a neutral tube containing 1 ml of sterile saline. In the laboratory, the tube will be vortexed for one minute and then 10μl of the sample will be seeded in oese calibrated on blood agar. Reading culture will be achieved after 48 hours at 35 ° C aerobically. The catheter will be considered settled if the count found most 1000 UFC / ml. Bacterial identification will be carried out by mass spectrometry and sensitivity by the diffusion method on Muller-Hinton agar. If there is more than one bacterial population, the number of PDUs for each bacterium was determined. In this case, we will consider only the bacterial types\> 1000 UFC / ml
24 months
perineural catheter infection
24 months
Skin preparation Use of 10 ml of 2% alcoholic Chlorhexidine "drug" for disinfection in place of povidone iodine without scrubing "device" Wait at least 30 secondes for drying Perineural catheterization implementation Ultrasonography use
Skin preparation Use of 10 ml of povidone iodine "drug" for disinfection with scrubing "device" Wait at least 30 seondes for drying Perineural catheterization implementation Ultrasonography use
Skin preparation (disinfection) with 10 ml of 2% alcoholic Chlorhexidine Perineural catheterization implementation Ultrasonography use
Chu Ambroise Pare
Boulogne-Billancourt, Île-de-France Region, 92100, France
Harkouk H, Thibault-Sogorb T, Beauchet A, Espinasse F, Lawrence C, Martinez V, Fletcher D. Two per cent alcoholic chlorhexidine versus alcoholic five per cent povidone-iodine for the prevention of perineural catheter colonisation: The CHLOVEPI randomised, controlled trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100790. doi: 10.1016/j.accpm.2020.100790. Epub 2020 Dec 5.
hakim harkouk, CCA
GH Raymond Poincaré-Ambroise Paré
First Submitted
January 20, 2016
First Posted
November 1, 2016
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 15, 2018
Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences
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Study Completion
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 18, 2018
Record last verified: 2018-07
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