Appendix: Table 6.
Summary of Evidence for Using C-I Dressings among Patients Aged ≥ 18 Years with Short-term, Non-tunneled Central Venous Catheters (data directly extracted from studies unless otherwise noted)
|Study Features||Population and Setting||Study Groups||Outcome Definitions||Results|
Risk of bias score: LowK
|N = 1,879 patients;
4,163 catheters (1,531 patients had CVCs, 1,666 patients had arterial catheters) [Methods did not specify if patients concurrently used more than 1 type of catheter.];
34,339 catheter days.Inclusion criteria: ICU patients >18 years old and expected to require intravascular catheterization for at least 48 hrs.Exclusion criteria: Patients with known allergies to chlorhexidine or transparent dressings.Setting: 12 ICUs in 7 university hospitals and 4 general hospitals.Location: FranceDates: May 2010–July 2011Anticipated study power: 80% to detect a 61% reduction in the 3% CRI rate. At least 2 catheters per patient were expected so study planned to enroll 1,888 patients (>3,776 catheters).Follow up: 48 hrs post ICU discharge
n= 938 patients, 2,108 catheters,
transparent C-I gel dressingControl:
n= 941 patients/2055 cathetersStandard, breathable, hypoallergenic dressing: n=476 patientsHighly adhesive dressing: n=465 patientsStandard care for both groups:
Insertion sites: radial artery or subclavian vein unless sites carried an increased risk of noninfectious complications (including femoral site).Maximal sterile barrier precautions: used at catheter insertionCatheters: CVC, arterial, tunneled CVC, and guidewire exchange. No antibiotic impregnated catheters were used. Single, double, and triple lumen catheters were used.Skin preparation: alcoholic PI or alcoholic CHG in accordance with standard procedure in each ICU. Skin preparation agent did not differ by study group.Dressing change: 24 hrs after insertion then every 3 or 7 days according to standard practice in ICU.Daily chlorhexidine bathing: not used in any ICUL
|Catheter-related bloodstream infection (CRBSI): A combination of:
Major catheter-related infection (CRI): Either catheter-related sepsis (CR-sepsis) without BSI or CRBSI
CR-sepsis without BSI: combination of all of the following:
Sepsis or BSI was declared as CR when there was no other detectable cause of sepsis with or without BSI. Non-cultured catheters were classified as not colonized unless there was sepsis with no other detectable cause.
Systemic adverse reaction to CHG: Not defined
Severe contact dermatitis requiring permanent discontinuation of dressings: Not defined but confirmed by a dermatologist. Study noted: “Contact dermatitis usually occurred for a single catheter per patient and selectively affected patients with multiple organ failure, subcutaneous edema, and fragile skin.”
Skin conditions rated with standard scale: The condition of the skin was described on standardized form by nurse in charge of patient at each dressing change and at catheter removal, using the International Contact Dermatitis Research Group (ICDRG) system: 1=mild redness only, 2=red and slightly thickened skin, 3= intense redness and swelling with coalesced large blisters or spreading reaction. Scores constituting “abnormal score” were not defined.
|CRBSI incidence (events/patients):
CRBSI rate (events/1,000 catheter days):
Major CRI incidence (events/patients):
Major CRI rate (events/1,000 catheter days):
Systemic Reactions: None occurred
Incidence of severe contact dermatitis requiring permanent discontinuation of dressing (events/patients): 22/938 (2.3%) vs. 5/941 (0.5%); p<0.01
Abnormal ICDRG score rate: (denominator unit NR): 2.3% vs. 1%; p<0.01
Risk of bias score: LowK
Study objective: To evaluate whether chlorhexidine–impregnated sponge dressing reduced CVC- related colonization and infections with or without associated bacteremia.
|N= 306 patients; 306 CVCs; 2,202 catheter days (not reported if tunneled or non-tunneled CVCs)
Exclusion criteria: Neutropenic patients, pregnant women, patients with expected ICU stay <3 days, patients with allergy to CHG; catheter changes over guidewire; and patients who were readmissions
Setting: 5 general ICUs
Dates: June 2006–May 2008
Anticipated study power: 80% power to detect a 50% reduction in catheter colonization rate of either study group. This would require 219 catheters per group. The study was stopped early due to slow recruitment
Follow Up: Until catheter removal or transfer from the ICU to another ward if discharged from ICU with catheter in place
N = 150 patients (restricted to first catheter per patient)C-I sponge under transparent, semipermeable, polyurethane, occlusive dressing placed after first 24 hrsControl:
N = 156 patients(restricted to first catheter per patient in study)Transparent, semipermeable, polyurethane, occlusive dressing alone placed after first 24 hrs.
Standard care for both groups:Insertion sites: internal jugular, femoral, and subclavian veins.Catheters: Triple lumen, polyurethane, uncoated, non-heparin-bonded CVCsSkin preparation: 10% PIDressing change: Gauze was placed over insertion site for first 24 hrs. After this, insertion sites were covered by intervention or control group dressings. Dressings for both groups were changed for the first time 24 hrs after CVC insertion and then every 3 days or sooner if considered soiled.Daily chlorhexidine bathing: Performed in 1 of the 5 ICUs (these patients comprised approximately 40% of the study population.)L
Formicroorganisms other than CoNS: CRI plus 1 positive blood culture from peripheral venous puncture growing the same microorganism as that isolated from the catheter tip. Contaminated cultures: 1 single blood culture, or 1 of 2 or more blood cultures found positive for CoNS.For CoNS: two or more peripheral blood cultures with a minimum delay of 1 hr, testing positive for CoNS, and having the same antibiotic susceptibility profile were required.CRI: Positive quantitative culture (≥103 CFU/mL) of the catheter tip plus clinical evidence of sepsis, in the absence of additional sites of infection with the same microorganism.Sepsis: Temperature >38.2°C or <36.5°C or chills, leukocytes ≥10,000 or ≤4,000, or other signs of sepsis.Product-related adverse events: Not definedAllergic reaction to chlorhexidine: Not definedSevere contact dermatitis: Not definedMild local redness: Not defined
|CRBSI incidence (events/patients): 3/150 (2%) vs. 2/156 (1.28%);HR: 1.65 (CI: 0.27–10.01)
CRBSI rate (event/1,000 catheter days): 2.84/1,000 vs. 1.4/1,000; p=0.59
CRI incidence (events/patients): 6/150 (4%) vs. 9/156 (5.77%); HR:0.65 (CI: 0.23–1.85); p=0.42
CRI rate (events/1,000 catheter days): 5.69/1,000 vs. 7.83/1,000
Product–related adverse events: All patients tolerated the C-I dressing well.
Allergic reaction to chlorhexidine: No patient was excluded due to allergic reaction to chlorhexidine.
Severe contact dermatitis incidence: None
Mild local redness incidence (events/patients): 1/156 (0.6%) vs. 0; this case resolved after dressing removal
Risk of Bias Score: LowK
Study objective: To evaluate the respective effects of using CHG-impregnated sponge dressing and increasing the time between dressing changes in adult patients in ICU.
|N = 1,636 patients; 3,778 arterial catheters and CVCs; 28,931 catheter-days
Inclusion criteria: Patients older than 18 years expected to require an arterial catheter, CVC, or both inserted for 48 hrs or more.
Exclusion criteria: Patients with a history of allergy to CHG or to transparent dressings.
Setting: ICUs in 3 university hospitals and 2 general hospitals
Dates: December 20, 2006–May 20, 2008
Anticipated study power: 80% to detect 60% reduction in the major CRI rate in the control group. It was hypothesized that each patient would have 2 catheters and the study planned to enroll 1,600 patients
Follow up: 48 hrs post-ICU discharge. Catheters were removed when no longer needed or a CRI was suspected
|Intervention: n=817 patients (in ITT analysis)C-I sponge under semipermeable, transparent dressing. This was changed after first 24 hrs
Control: n=819 patients (in ITT analysis)
Semipermeable transparent dressing alone.
Standard care for both groups: All centers followed French guideline recommendations for catheter insertion and care.
Insertion sites: CVC: jugular, subclavian, and femoral. Arterial catheters: femoral and radial
Catheters: CVCs (both tunneled and percutaneous [non-tunneled]) and arterial catheters were used. No antiseptic or antibiotic impregnated CVCs used.
Skin preparation: Alcoholic PI solution (5% PI in 70% alcohol)
Dressing change: 24 hrs after CVC insertion, then every 3 days or 7 days, or sooner if soiled or leaking.
Daily chlorhexidine bathing: None
|CRBSI: a combination of
Major CRI: either CR sepsis without BSI or CRBSI.
Catheter-related sepsis without BSI: combination of
Systemic adverse reactions: Not defined
Severe contact dermatitis: Not defined. However, suspected contact dermatitis or skin allergy was confirmed by a dermatologist.
Skin condition: The condition of skin was described on a standardized form by the nurse in charge of the patient at each dressing change and at catheter removal using the International Contact Dermatitis Research Group (ICDRG) system: 1=Mild redness only, 2=red and slightly thickened skin, 3= Intense redness and swelling with coalesced large blisters or spreading reaction. Scores constituting “abnormal score” were not defined.
Chlorhexidine resistance: Minimum bactericidal concentration (MBC) of chlorhexidine was determined for 106 strains cultured from the skin at catheter removal. Results reported as median MBC (IQR).
|CRBSI incidence (events/catheters): All catheter types: 6/1,953 (0.3%) vs. 17/1,825 (0.9%); HR:0.24 (CI: 0.09–0.65); p<0.01
CRBSI rate (events/1,000 catheter days): 0.4/1,000 vs. 1.3/1,000
Major CRI incidence (events/catheters):
All catheter types: 10/1,953 (0.5%) vs. 19/1,825 (1%); HR:0.39 (CI: 0.16–0.93); p=0.03
Major CRI Rate (events/1000 catheter days):
All catheter types: 0.6/1,000 vs. 1.4/1,000
Subanalysis that combined patients with either C-I dressing or standard dressings found no significant differences in CRBSI rates related to frequency of dressing changes (every 3 days vs. every 7 days).
Systemic adverse reactions to chlorhexidine: None
Severe contact dermatitis that required removal of dressing:
Abnormal ICDRG score rate (events/catheter): 100/6,720 (1.49%) vs. 63/5,875 (1.02%); p=0.02
Skin allergy to transparent adhesive dressing incidence (events/catheters): 1/1,953 (<0.01%) vs. 1/1,825 (<0.01%)
Median MBC of chlorhexidine (IQR): 4 (4–8) vs. 4 (4–16); p=0.30
MBC of chlorhexidine > 32: 5 events/52 strains vs. 4 events/52 strains
Risk of bias score: ModerateK
|N = 601 patients; 601 non-tunneled CVCs; 9,731 catheter days
Inclusion criteria: Hematology and oncology patients requiring a CVC for at least 5 days
Exclusion criteria: Those expected to have their CVC for less than 5 days
Setting: 1university hospital
Dates: January 2004–January 2006
Anticipated study power: 80% power to detect a reduction in CRBSI from an estimated 6% in the control group. 707 patients were planned per group.
Study reached statistical difference at second interim analysis and enrollment stopped.
Follow up: NR
|Intervention: n=300 patients (a single catheter per patient was included)C-I sponge under transparent polyurethane dressing
Control: n=301 patients (a single catheter per patient was included)
Transparent polyurethane dressing alone
Standard care for both groups:
Catheters: all patients received a chlorhexidine and silver sulfadiazine-impregnated triple lumenCVC
Skin preparation: alcohol spray
Dressing change: weekly or after having been lifted up for inspection controls
Daily chlorhexidine bathing: NR
|CRBSI: Proven infection with the time to positivity method: 1 of the catheter-drawn blood cultures (taken through each lumen of the CVC) became positive at least 2 hrs earlier than the culture of a peripheral venipuncture blood draw after skin disinfection, and clinical signs and symptoms [fever (>38.0C by ear thermometer measurement), swelling, and/or hypotension; tenderness, erythema, swelling around the catheter insertion site; or elevated CRP levels suggesting infection]for which no other source than the catheter was identified.
Product-related adverse effects: not defined
Allergic reactions: not defined
Chlorhexidine resistance: not defined
|CRBSI incidence (events/patients): 19/300 (6.3%) vs. 34/301 (11.3%); RR: 0.54 (CI: 0.31–0.94); p=0.02
CRI rate (events/1,000 catheter days): 3.8/1,000 vs. 7.1/1,000
Product related adverse events: No complications of CVC insertion were observed except infections
Patients excluded from study due to allergic reactions: none
Chlorhexidine resistance: No suspicion of bacterial resistance to chlorhexidine dressings
Risk of bias score: ModerateK
Study objective: To determine the effects of C-I sponge dressings on the rates of CVC tip and exit site infection/colonization in an adult ICU
|N = 32 patients and 40 CVC enrolledData available for 33 non-tunneled CVCs
Inclusion criteria: All patients receiving CVCs in the ICU during 7-week period
Exclusion criteria: NR
Setting: 1 teaching hospital ICU
Location: West Australia
Anticipated study power: 80% power to detect a 10% reduction in colonization rates (primary outcome) based on 11,000 patients
Follow up: NR
|Intervention: n=17 cathetersC-I sponge under occlusive dressing
Control: n=16 catheters
Occlusive dressing alone
Standard care for both groups:
Insertion site: NR
Catheters: non-tunneled CVCs inserted over guidewire (Seldinger technique)
Skin preparation: 0.5% chlorhexidine in 70% alcohol.
Dressing change: dressings attended to every fifth day or as needed
Daily chlorhexidine bathing: NR
|CRI: Any infection in which the organism isolated from the CVC tip and/or exit site was the same as that isolated from a clinical isolate associated with clinical signs (elevated temperature and white cell count).||CRI incidence (events/catheters): 1/17 (5.9%) vs. 0/16 (0%); p=NS. In a single infection, isolates from both the catheter exit site and catheter draw were S. epidermis with identical antibiotic susceptibilities.|
K Basis of score described in Table 8.
L Information obtained via correspondence with author.
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- Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009;301(12):1231-1241.
- Ruschulte H, Franke M, Gastmeier P, et al. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009;88(3):267-272.
- Arvaniti K, Lathyris D, Clouva-Molyvdas P, et al. Comparison of Oligon catheters and chlorhexidine-impregnated sponges with standard multilumen central venous catheters for prevention of associated colonization and infections in intensive care unit patients: a multicenter, randomized, controlled study. Crit Care Med. 2012;40(2):420-429.
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