Chlorhexidine dressings show promise despite premature study closure

A randomized trial assessing whether chlorhexidine-containing catheter securement dressings could significantly reduce the incidence of definite central venous catheter–related bloodstream infections within 14 days of catheter placement failed its primary endpoint, according to result of an open-label, randomized controlled study published in Annals of Oncology.

However, use of catheter securement dressings reduced the incidence of definite or probable central venous catheter–related bloodstream infections, results showed.

Central venous catheter–related bloodstream infections are a leading cause of mortality among patients with hematologic cancers and chemotherapy-induced neutropenia. Prior randomized studies have suggested that the use of chlorhexidine dressings may reduce the incidence of central venous catheter–related bloodstream infections.

Maria J.G.T. Vehreschild, MD, professor of internal medicine at University Hospital of Cologne in Germany, and colleagues assigned 613 patients with neutropenia to securement dressings containing chlorhexidine gluconate gel pads (Tegaderm, 3M; n = 307) or a securement dressing without chlorhexidine (n = 306).

The dressings were applied within 2 hours of central venous catheter placement and changed every 3 days. The researchers took central and peripheral blood cultures in cases of neutropenic fever, and catheter removal occurred in suspected cases of central venous catheter–related bloodstream infections.

The incidence of definite central venous catheter–related bloodstream infections within 14 days of catheter placement served as the primary endpoint. Secondary endpoints included definite or probable central venous catheter–related bloodstream infections within 14 days, overall central venous catheter–related bloodstream infections, the incidence of unscheduled dressing changes and adverse events.

The incidence of definite central venous catheter–related bloodstream infections within 14 days did not significantly differ between groups (chlorhexidine, n = 8; control, n = 12; OR = 0.67; 95% CI, 0.27-1.69).

Despite this, chlorhexidine-containing dressings resulted in significantly fewer definite central venous catheter–related bloodstream infections (6.5% vs. 11.1%; P = .047) and probable central venous catheter–related bloodstream infections (10.4% vs. 17.3%; P = .014).

No significant differences occurred in the incidence of infection-related sepsis and mortality, overall mortality, time to catheter removal and time to first neutropenic fever.

Further, both groups had similar rates of dressing intolerance in the contact area (chlorhexidine vs. control, 12.4% vs. 11.8%). However, the patients in the chlorhexidine group had significantly fewer unscheduled dressing changes (269 vs. 362; P = .030).

Adverse event rates were similar in both groups (chlorhexidine, n = 56; control, n = 57). Events related to cutaneous and soft tissue abnormalities occurred frequently (chlorhexidine, n = 38; control, n = 36); these led to study discontinuation or definitive change to different dressing in 46 patients (chlorhexidine, n = 22; control, n = 24).

The researchers observed a total of 78 serious adverse events (chlorhexidine, n = 42; control, n = 36); however, none were deemed treatment related.

The study closed at the time of the analysis due to the low rate of primary endpoint events.

“The study was not able to demonstrate a reduction in the primary endpoint of definite central venous catheter–related bloodstream infections within 14 days of central venous catheter placement by the application of transparent central venous catheter dressings with a chlorhexidine-containing gel pad in patients undergoing intensive chemotherapy,” Vehreschild and colleagues wrote. “The presented results show that the dressings were well tolerated and significantly reduced definite and probable central venous catheter–related bloodstream infections. Whether the observed risk reduction for definite and probable central venous catheter–related bloodstream infections justifies the application of chlorhexidine gluconate dressings in the routine care of long-term neutropenic patients also depends on further factors, such as local central venous catheter–related bloodstream infection rates and related costs.” – by Cameron Kelsall

Disclosure: 3M provided funding for this study. Vehreschild reports research funding from, as well as consultant and/or speakers bureau roles with, 3M, Astellas, Berlin Chemie, DaVolterra, Gilead Sciences, Merck and Pfizer. Please see the full study for a list of all other researchers’ relevant financial disclosures.