Chlorhexidine Sponge Dressing

To evaluate the effectiveness of oligon central venous catheters (CVC) and chlorhexidine biopatch to reduce CVC-related infections. Oligon catheters are impregnated with antimicrobial silver, platinum, and carbon.

Patients were randomized to receive either a standard polyurethane catheter, a standard catheter plus biopatch, or an oligon catheter. All catheters were triple lumen. Standard maximum barrier insertion techniques were used, and dressing change frequency was every three days with a transparent dressing. Those getting the biopatch had the biopatch changed with regular dressing changes. The primary study endpoint was catheter colonization. A decision to remove the catheter was made by individual physicians.

• N = 376; 465 in intention to treat analysis
• MEDIAN AGE = 59 years
• AGE RANGE = 32–73 years
• MALES: 69.7%, FEMALES: 30.3%
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: Overall, 7% of the sample had cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: 96% of patients were in the ICU for mechanical ventilation.

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

• Three-group randomized, controlled trial (RCT)

• Catheter colonization defined as 10³ or greater colony forming units ml of catheter tip
• Catheter-related infection (CRI) defined as positive colonization and clinical evidence of sepsis with the same organism and no other clinical site for infection
• Central line–associated bloodstream infection (CLABSI) defined as CRI plus one positive peripheral blood culture with the same organism as isolated from the catheter tip

There were no differences in catheter colonization rates, CRI, or CLABSI between groups. There were no differences between groups in number of catheter days, CLABSI incidence per 1,000 catheter days, or other factors potentially associated with development of CLABSI. Analysis showed that use of jugular or femoral insertion site and cancer diagnosis were significantly associated with development of catheter colonization (p < 0.05).

Findings did not support efficacy of BIOPATCH dressings or antimicrobial catheters for prevention of catheter-related colonization or infections.

• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• The study was underpowered. Patients receiving BIOPATCH dressing and impregnated catheters had significantly lower proportion of patients. No data regarding actual adherence to insertion and dressing change protocols existed.

Findings did not show efficacy of chlorhexidine-BIOPATCH CVC dressings or antimicrobial impregnated short-term catheters to prevent catheter colonization and related CVC-infection related outcomes.

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

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.

• 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.

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

PHASE OF CARE: Active antitumor treatment

• Randomized, open-label

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

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).

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.

• 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.

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.

The purpose of the study was to evaluate the efficacy of sustained-release chlorhexidine (CHX) dressings versus standard dressings.

All adult patients admitted under the hematology service that were to receive chemotherapy and had a tunneled cuffed central intravascular catheter inserted were eligible for inclusion. After insertion, all tunneled intravascular catheters were randomized, but they were treated in the same manner with a sterile gauze and porous adhesive dressings until the exit site was dry and free from ooze. Those randomized to standard catheter exit-site treatment (control group) received no dressing in accordance with BCHS guidelines. The CHX group (intervention group) were treated with CHX dressings consisting of a 2.5 cm hydrophilic polyurethane foam disk containing CHX gluconate in a sustained-release formulation. These were applied to the exit site as soon the oozing had stopped following intravascular catheter insertion, and changed as needed or weekly until the catheter was removed. The same treatment was continued for the life of the catheter but if an intravascular catheter was removed and replaced, the new catheter was randomized. Exit site and tunnels were routinely examined on a weekly basis.

The primary endpoint of this study was the development of exit-site and/or tunnel infection. The secondary endpoint was removal of the catheter for infection. In total, 114 tunneled intravascular catheters in 95 patients were randomized from August 1998 to December 2001.

• The total sample consisted of 95 patients.
• Mean age of the control group was 49 years (range = 16–70); mean age of the CHX group was 50 years (range = 15–68).
• Chemotherapy infusion was a key disease characteristic
• Total catheters in the control group were 43. 
• Total catheters in the CHX group were 52. 
• Malignancies: acute nyeloid leukemia (17% control, 17% CHX), non-Hodgkin lymphoma (9% control, 11% CHX), myeloma (5% control, 9% CHX), acute lymphoblastic leukemia (3% control, 6% CHX), breast (2% control, 1% CHX), chronic myeloid leukemia (2% control, 1% CHX). Other malignancies (amyloidosis, Ewing sarcoma, renal cell carcinoma, myelodysplasia and aplastic anemia) accounted for 6% of the CHX group.
   

A single-site inpatient hematology unit

• There were multiple phases of care
• Clinical applications were for late effects and survivorship
   

Prospective, randomized

 All patients received a 10F vascular catheter with a surecuff tissue ingrowth, vitacuff antimicrobial cuff inserted percutaneously by a radiologist using the Seldinger technique.

Definitions used:

• Exit site infection: redness, pain, and tenderness at the exit site less than 2 cm from the skin along the intravascular catheter of sufficient degree to warrant antimicrobial therapy as judged by the attending medical team.
• Tunnel infection: pain, tenderness, and swelling over the subcutaneous tunnel more than 2 cm from the exit site.
• Bacteraemia: presence of one or more species of organism in two sets of blood cultures within 24 hours (both sets from peripheral vein or one set from peripheral vein and one from central catheter).
• Intravascular catheter-related bacteraemia: evidence of bacteraemia in the presence of fever but no recognized focus of infection, with the same organism recovered from the catheter tip as from the blood cultures or exit site.
• Suspected intravascular catheter infection: positive blood cultures drawn in the presence of fever (single measure higher than 38.5ºC or two measures higher than 38ºC) with no other recognized focus of infection, causing the catheter to be removed prematurely.
• Intravascular catheter infection: suspected catheter infection in which the culture of the tip yielded more than 15 colonies of the same organism as was found in the blood cultures drawn from either the catheter or from the periphery.
• Neutropenia: less than 0.5 x 10⁹ neutrophils/L

This study has shown  that the use of CHX dressings was associated with less exit site infections (OR = 0.13, 95% CI [0.04, 0.37], p < 0.001). The rate of premature catheter removal for these infections was reduced approximately three fold in the CHX group (OR = 0.23, 95% CI [0.07, 0.77]). The failures of the CHX dressing group were associated either with a very early occurrence after insertion of the catheter, suggesting that the infecting organisms were implanted at the time of catheter insertion, or with delays in application of the CHX dressing. Positive blood cultures occurred in fewer patients in the control group (p < 0.01) with less isolates of gram-positive organisms in the control group (p < 0.05).

This study demonstrated that use of the sustained-release CHX dressing was associated with reduced extralumenal catheter infections; however, it was not associated with fewer blood stream infections.

• Small sample size (less than 100 participants)
• There was a risk of bias favoring the CHX group because the clinical team was not blinded to treatment. 
• Results were reported in terms of patients and various time points and could have been more  clear if reported in terms of total or cumulative patient catheter days. 
• No results of defined outcomes such as suspected catheter infection, etc., were reported. 
• It is unclear how immunosuppressed the sample was in order to draw relevant conclusions.
   

Sustained-release CHX dressings may help to reduce some central line-associated infections in patients with cancer who are at risk and in whom other aspects of catheter insertion and care are in place.  Further well-designed research in this area is warranted.

To evaluate the effectiveness of chlorhexidine sponges in prevention of central venous catheter infections inserted for cancer chemotherapy

All patients received chlorhexidine and silver-impregnated, triple-lumen central venous catheters (CVC) that were intended for at least five-day use. Catheter insertion was done using maximal barriers, and skin antisepsis was done with alcohol. Catheter dressings were changed weekly. Patients expected to have catheters in place for less than five days were not included in the study.

• N = 601   
• MEDIAN AGE = 47
• AGE RANGE = 18–73
• MALES: 55.4%, FEMALES: 44.6%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had hematological malignancies
• OTHER KEY SAMPLE CHARACTERISTICS: The majority had CVCs placed in the internal jugular vein

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Germany

• PHASE OF CARE: Active antitumor treatment

• Stated randomized, controlled trial

• Diagnosis of central line–associated bloodstream infection (CLABSI) was made based on clinical assessment symptoms of fever, swelling, and/or hypotension for which no other source was identified.

Mean catheter duration was 15.8 days among controls and 16.6 days in the experimental group. Among the treatment group were 19 cases of CVC infection (3.8 per 1,000 catheter days) compared to 34 cases (7 per 1,000 catheter days) in the control group (p = 0.016).

The use of chlorhexidine-impregnated dressings was associated with a lower rate of catheter-related infections.

• Risk of bias (no blinding)
• Measurement/methods not well described
• No information on the chemotherapy agents used
• Unclear definition of catheter-related infection by clinical determination
• Stated as an RCT, but randomization was not described and usual care not described 
• Stated that experienced clinician inserted the experimental group catheters, and procedure described
• Information about insertion or sites for \"control\" group was not described.

This study demonstrated supportive evidence for efficacy of chlorhexidine-impregnated dressings in CVC care to reduce the incidence of catheter-related infections. Patients with hematologic cancers receiving chemotherapy as included here are generally at high risk for infection. Interventions that can reduce the risk of infection in this patient population are important to incorporate into practice.

To assess chlorhexidine-impregnated sponge dressings for prevention of catheter-related infections

Patients were randomly assigned to one of four treatment groups. Groups were (a) standard dressing every three days, (b) chlorhexidine sponge dressing every three days, (c) standard dressing every seven days, and (d) chlorhexidine dressing every seven days. Insertion sites were the radial artery or subclavian vein whenever possible. Insertions were done with maximal barriers and antisepsis techniques. Semitransparent dressings were used for all. Povidone-idodine was used for skin antisepsis with each dressing change. Patients were followed for 48 hours after discharge from the ICU. A noninferiority analysis was planned with the identification of a 3% difference in catheter-related infection (CRI) rate as the comparison value. Only cultured catheters were considered to compare three- versus seven-day dressing intervals.

• N = 1,636 in intent to treat analysis, 28,931 catheter days   
• MEDIAN AGE = 62 years
• AGE RANGE = 50–74 years
• MALES: 64.3%, FEMALES: 35.7%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: 64 patients (3.9%) had metastatic cancer and 52 (3.2%) had hematologic cancer
• OTHER KEY SAMPLE CHARACTERISTICS: 45% were arterial catheters and, of these, 41% were femoral; 54.3% were venous catheters and, of these, 40% were subclavian; the rest were jugular or femoral catheters.

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

• Four-group, single-blind randomized, controlled trial

• CRI defined as either catheter-related sepsis without bloodstream infection or catheter-related bloodstream infection. 
• Catheter colonization was the major outcome for comparison of three- versus seven-day dressing intervals
• Catheter colonization: At least 1,000 colony forming units/ml
• CRI defined as combination of (a) body temperature ≥ 38.5 C or hypothermia, (b) catheter tip culture with at least 10³ CFUs/ml, (c) pus at insertion site or resolution of clinical sepsis with catheter removal, and (d) absence of any other foci for infection.

Use of chlorhexidine dressings overall were associated with a 0.6 CRI rate compared to 1.4 in the control groups per 1,000 catheter days (hazard ratio [HR] = 0.39, p = 0.03). Of those assigned to seven-day dressings, 50.6% had more frequent unplanned dressing changes. There was no significant difference in colonization rate between those having three- and seven-day dressing intervals. There was a slight but insignificant increase in skin colonization in the seven-day group at the time of catheter removal. Overall, the rate of central line–associated bloodstream infection (CLABSI) was lower (p = 0.005) with sponge dressings. 

Use of chlorhexidine sponge dressing reduced the incidence of catheter-related bloodstream infections. Analysis by dressing change interval did not show any significant difference in outcomes.

• There was no analysis of each separate group to determine which combination of dressing frequency and dressing type was most effective.  
• Low volume of patients with cancer
• No subgroup analysis by catheter insertion site. A rather large proportion were femoral and jugular sites.

Findings showed lower CLABSI rate and risk with use of chlorhexidine-impregnated sponge dressings. Findings also suggest no difference in infection outcomes related to catheters according to the frequency of dressing changes, although more than half of patients assigned to dressing changes every seven days needed changes more frequently for soiling or separation. Chlorhexidine-impregnated dressings can reduce CLABSI rate, and less frequent catheter dressing changes can be done with no apparent increase in infections.

To provide evidence-based recommendations for the prevention of intravascular catheter-related infections for healthcare personnel who insert and care for intravascular catheters and for those responsible for surveillance and infection control in hospital, outpatient, and home health settings. Patients addressed in the guidelines were adult and pediatric patients with intravascular catheters.

The resource is comprised of evidence-based guidelines. For the development process, evidence was categorized as category 1A to category 2 based on strength of recommendation and support from clinical or epidemiological studies.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for pediatrics. 

The results were not summarized.

The guidelines provided extensive recommendations regarding the education and training of staff; selection of catheters and sites, including avoidance of the femoral vein for central venous access and use of the central venous catheter with the minimum number of ports needed; hand hygiene; use of maximal sterile barrier precautions for insertion; skin preparation with alcohol, iodine, or chlorhexidine; use of standard catheter site dressing regimens; specific aspects of care for umbilical and dialysis catheters; and use of piggybacks, stopcocks, and catheter flushing. Guideline recommendations include a bundling of multiple recommendations: antimicrobial-impregnated catheters and cuffs are recommended in patients with long-term use if the organizational central line-associated blood stream infection (CLABSI) rate is not decreasing despite the implementation of comprehensive strategies for improvement. Lower-level (category II) recommendations include the use of prophylactic antimicrobial lock solutions in patients with long-term catheters who have a history of CLABSIs despite optimal aseptic technique as well as daily cleansing of patients in the intensive care unit with 2% chlorhexidine-impregnated washcloths. Recommends changing IV administration sets no more often than every 96 hours unless used for blood products. For needleless components, recommends changing according to administration set timing as above, and states no benefit to changing more than every 72 hours.

Provides extensive recommendations for management of all types of intravenous catheters and system components. Nurses should refer to the full set of guidelines for all specific aspects of care.