Clinical Trial Evaluating a New Hub Device Designed to Prevent Catheter-Related Sepsis

Abstract

A new commercial hub device designed to minimise catheter-related infections was evaluated in a prospective, randomised trial in the intensive care and surgical units of the Hospital de Tortosa Verge de la Cinta in patients in whom the central venous catheters were expected to remain indwelling for at least 7 days. The assessments conducted at catheter withdrawal included cultures of the skin at the catheter site and cultures of the catheter tip and the catheter hubs; moreover, in cases of suspected catheter-related sepsis, samples of peripheral blood and infusion solutions were also cultured. Of the 130 catheters evaluated, 26 (20%) were withdrawn because of suspected catheter-related sepsis; 10 (15%) were in the control group and 16 (24%) in the new product group. Catheter-related sepsis was diagnosed in nine patients, six of whom were in the new product group and three in the control group; all infections in the former group and only one in the latter group were caused by the catheter connection. The rates of catheter hub colonisation (10 cfu) and catheter colonisation (15 cfu in semiquantitative culture and/or >1,000 cfu in quantitative culture) of hub origin were not significantly different between the groups (15 cases in the control group vs. 20 cases in the new product group, and 5 cases in the control group vs. 11 cases in the new product group, respectively). The data indicate that the use of the new catheter hub device is no more effective in preventing catheter-related infection than standard good clinical procedures.

Nosocomial infections in the intensive care unit associated with invasive medical devices

“…A novel CVC hub developed by Segura et al [57] contains a connecting chamber filled with iodinated alcohol and was shown in a randomized clinical trial to be associated with greatly reduced rates of CVC-related BSI (4% vs 16%, P = < 0.01), although a subsequent trial failed to show benefit with the novel hub [58]. Although noncuffed CVCs were studied in these trials, the catheters remained in place for much longer than is usual in US ICUs, amplifying the importance of the intraluminal route of CVC-related BSI.…”

Diagnosis, prevention, and management of catheter related bloodstream infection during long term parenteral nutrition

“…A hub including an iodinealcohol reservoir was shown to reduce CR-BSI fourfold in one study, 31 but failed to show benefit in a more recent investigation. 32 In randomised controlled trials in adult patients, catheters externally impregnated with chlorhexidinesilver sulphadiazine have been shown to reduce the incidence. [33][34][35] Coating both the internal and external catheter surfaces with minocycline and rifampicin significantly reduces the risk of colonisation and CR-BSI, 36 although this protection is short lived as the antibiotics are washed off.…”

Chlorhexidine-based antiseptic solutions effectively reduce catheter-related bacteremia

“…For the temporary catheters, the entry of the pathogen to the catheter can be through the exit site and the tunnel around the catheter (extraluminal hypothesis) [9][10][11]. Among the well-known preventive measures for CRB are the use of strict hygiene measures during placement and maintenance of the catheters, the application of preventive antimicrobial ointments/solutions at the exit site, the eradication of a Staphylococcus aureus nasal/skin carrier state, the cleansing of catheter hubs with antimicrobial solutions, the use of antimicrobial-coated catheters, and the intraluminal application of antibiotic lock solutions (ABLs) [5,[11][12][13][14][15][16].…”