Biehl, L.M., Huth, A., Panse, J., Kramer, C., Hentrich, M., Engelhardt, M., . . . Vehreschild, M.J. (2016). A randomized trial on chlorhexidine dressings for the prevention of catheter-related bloodstream infections in neutropenic patients. Annals of Oncology, 27, 1916–1922. 

DOI Link

Study Purpose

To compare the effects of chlorhexidine-containing dressings and nonchlorhexidine dressing on catheter-related infections (CRIs) in neutropenic patients

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either a transparent central venous catheter (CVC) dressing with a chlorhexidine gel pad or the transparent dressing without the gel pad. All catheters were nontunneled and placed in the subclavian or internal jugular vein with strict aseptic technique. Dressings were changed every 3–4 days. In the case of neutropenic fever, blood cultures were drawn, and if central line–associated bloodstream infections (CLABSI) were suspected, the catheter was removed and the tip was sent for culture. Patients were followed for 14 days.

Sample Characteristics

  • N = 613   
  • MEAN AGE = 58 years
  • AGE RANGE = 18–85 years
  • MALES: 57.3%, FEMALES: 52.7%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All were expected to have neutropenia for at least five days and expected CVC use of at least 10 days. All had hematologic malignancies. About half were undergoing autologous hematopoietic cell transplanation (HCT).
  • OTHER KEY SAMPLE CHARACTERISTICS: Over 90% were receiving antimicrobials.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Germany

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized, open-label

Measurement Instruments/Methods

  • Definite or probable catheter colonization—definite CLABSI was the primary endpoint
  • Catheter-related sepsis

Results

The study was discontinued early because the interim analysis did not show a significant difference in the primary endpoint of the study (definitive CLABSI) and further enrollment was not expected to make a difference. The incidence of probable bloodstream infection was less frequent in the study group (p = 0.014). No differences existed in sepsis, infection-related mortality. More unscheduled dressing changes occurred in the control group. Patients with coated CVCs had higher rates of catheter-related colonization and bloodstream infection (p = 0.007).

Conclusions

The use of a chlorhexidine gel pad CVC dressing was associated with a lower incidence of probable CLABSI but did not demonstrate a significant effect on definite catheter-related bloodstream infection within 14 days of CVC placement.

Limitations

  • Risk of bias (no blinding)
  • Key sample group differences that could influence results 
  • Measurement/methods not well described
  • The study was underpowered.
  • No complete subgroup analysis based on use of coated catheters
  • The definition of probable and definitive infection was not well described.

Nursing Implications

Although this study did not show an effect of chlorhexidine gel pad CVC dressings on definitive CLABSI within 14 days, the gel pad dressing was associated with a lower incidence of probable catheter-related infection. This study had a large sample but was underpowered because of an overall low incidence of definitive CLABSI. The findings suggest that the use of a dressing with a chlorhexidine pad may be beneficial in reducing catheter-related infections.