Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the published process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
Six randomised controlled trials including a total of 3,647 patients were selected for inclusion in this briefing. The evidence includes both children and adults needing venous or arterial catheters for at least 48 hours in secondary care settings. All included studies compared Biopatch with the standard care procedures for that healthcare setting.
One meta-analysis of chlorhexidine-impregnated dressings for preventing CRBSIs was also identified from the literature search (Safdar et al. 2014). This meta-analysis included 9 randomised controlled trials, of which 8 used Biopatch and 1 used a different chlorhexidine-impregnated dressing. The analysis reported that chlorhexidine-impregnated dressings were beneficial in preventing catheter colonisation. Because the results reported by the meta-analysis include results from both types of dressing, it has not been summarised in full in this briefing.
Three of the 4 studies that used rate of colonisation as a primary outcome found reductions in rates of colonisation at the catheter insertion site with Biopatch (Timsit et al. 2009, Levy et al. 2005 and Garland et al. 2001). Arvaniti et al. 2012 reported no difference between groups.
All randomised controlled trials included used either catheter-related infection or CRBSI as an outcome measure. Table 1 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
A general strength of the evidence was that a number of high quality comparative randomised studies were available. Appropriate randomisation methods were used across 5 of the 6 included trials, but the randomisation method for 1 trial was not reported.
There were some general limitations of the evidence. None of the studies was based in the UK so it is unclear how generalisable the results from these trials may be to an NHS setting.
There was an absence of double-blinded procedures. This was because there was not a visually comparable control dressing available at the time of testing. Therefore the clinical teams responsible for the inspection and changing of dressings were aware of which group the patients had been randomised to, potentially introducing bias into the study. In trials of medical devices it is often impossible to have double-blind studies because the interventions may be visibly different.
Three of the studies reported limited incidences of the outcome measures. This makes drawing conclusions from the results difficult and suggests that the trials were underpowered to detect a true difference between intervention and comparator, particularly in the main outcome of CRBSI.
Additionally, some of the patient populations included may not be representative of patients typically needing this device. For example, 1 study recruited children having cardiac care and 3 studies recruited patients having chemotherapy.
Table 1: Published evidence
|
Study size, design and location |
465 patients. RCT, multicentre, Greece. |
|
Intervention and comparator |
Control group plus 2 intervention groups:
Both intervention groups had the intervention and standard dressings. The control group had standard dressings only. |
|
Key outcomes |
No statistically significant difference in the number of CRBSIs between both intervention groups and the control group. No statistically significant differences in rate of catheter colonisation were found between both intervention groups and the control group. |
|
Strengths and limitations |
Moderate sample sizes in each group. Recruitment slowed in the last 6 months and so was halted early. This means that the study did not reach the size needed to reach its target of 80% power to detect a 50% reduction in colonisation rates. The patients did not give informed consent because this was waived by the institutional review boards of all participating hospitals. No comparison was done between the 2 intervention groups to determine which would be preferable. |
|
Study size, design and location |
95 patients. RCT, single centre, New Zealand. |
|
Intervention and comparator |
The intervention group had Biopatch in addition to sterile gauze and adhesive dressings after insertion. The control group had sterile gauze and adhesive dressings after insertion but no dressing after the wound stopped oozing. |
|
Key outcomes |
CRBSIs were statistically significantly reduced in the intervention group. There was no statistically significant difference between groups in relation to premature removal of catheters because of infection. |
|
Strengths and limitations |
Does not report significance levels for demographic differences between groups. The incidence of CRBSI was very low. This could have been because of the sample sizes being too small. |
|
Study size, design and location |
705 patients. RCT, multicentre, US. |
|
Intervention and comparator |
The intervention group had catheter insertion site cleansing using 70% isopropyl alcohol for 30 seconds with the application of Biopatch. The comparator group had catheter site insertion cleansing with 10% povidone-iodine with the application of a polyurethane dressing. |
|
Key outcomes |
There was a statistically significant reduction in the rate of catheter colonisation in the intervention group. There was no statistically significant difference in the number of CRBSIs or bloodstream infections without a source between groups. |
|
Strengths and limitations |
Baseline characteristics between groups were comparable. Because of funding constraints the recruitment was halted early. This means that the study did not reach the size needed to reach its target of 80% power to detect a 50% reduction in CRBSI risk. The Biopatch group had a different antisepsis method before catheter insertion than the comparator group. This is a possible confounder. |
|
Study size, design and location |
145 patients. RCT, single centre, Israel. |
|
Intervention and comparator |
The intervention group had Biopatch as well as the standard transparent polyurethane dressing. The control group had the standard transparent polyurethane dressing only. |
|
Key outcomes |
Colonisation rates were statistically significantly lower in the intervention group. The incidence of CRBSIs was slightly higher in the intervention group compared to the control group but this did not reach statistical significance. |
|
Strengths and limitations |
The statistical significance level of colonisation was borderline (0.046) and should be interpreted with caution. Incidence of CRBSI was very low. |
|
Study size, design and location |
601 patients. RCT, single centre, Germany. |
|
Intervention and comparator |
The intervention group had Biopatch as well as a standard transparent wound dressing. The control group had a standard sterile transparent wound dressing. |
|
Key outcomes |
Numbers of CRBSIs were statistically significantly reduced in the intervention group compared with the control group. |
|
Strengths and limitations |
Moderate and comparable samples. A possible confounder is that the catheters were kept in for a very long time compared to other studies (about twice as long). This increases the risk of infection irrespective of any extra precautions taken. The statistics reported in this study are misleading because some are based on each sample (for example percentage of control patients and percentage of intervention) and some are based on the sample as a whole (such as percentage of all internal jugular vein or subclavian patients). |
|
Study size, design and location |
1,636 patients. RCT, multicentre, France. |
|
Intervention and comparator |
The intervention consisted of Biopatch, applied to the entire skin surface at and around the catheter insertion site, followed by the application of standard dressings. The comparator consisted of standard dressings applied to the catheter insertion site. The study had additional 3-day and 7-day dressing change subgroups in both the intervention and control groups. |
|
Key outcomes |
Major CRIs (defined as catheter-related sepsis with or without bloodstream infection) were statistically significantly reduced in the intervention group. Catheter colonisation was statistically significantly reduced in the intervention group. CRBSIs were statistically significantly reduced in the intervention group. There was no statistically significant difference in catheter colonisation between the 3-day and 7-day dressing change subgroups. |
|
Strengths and limitations |
Large sample size across multiple centres. CHG was not used as a skin preparation even though this is considered to be a standard care procedure. |
|
Abbreviations: CRBSIs, catheter-related bloodstream infections; CRIs, catheter-related infections: CVCs, central venous/vascular catheters; RCT, randomised controlled trial. |
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Recent and ongoing studies
The following relevant ongoing studies were found on ClinicalTrials.gov:
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NCT00548132 – Reducing Catheter-Related Bloodstream Infections in the ICU with a Chlorhexidine-Impregnated Sponge (BIOPATCH). Completed with results as of August 2013.
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NCT00550693 – Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH) to Reduce Catheter-Related Bloodstream Infections in Haemodialysis Patients. Study is completed but with no results reported. Study completion date was set as March 2005 with no primary completion date given.
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NCT00417235 – Dressing: Frequency of Change and Evaluation of an Antiseptic-Impregnated Catheter Dressing in ICU Patients. Completed but with no results posted. Primary and study completion dates were set as June 2008.
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NCT01112020 – Components of Chlorhexidine Gluconate Dressing. Study is completed but with no results posted. Primary completion and study completion dates were set as May 2010.