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Updated Recommendations on the Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections (2017)

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

Timsit, 20121
(Extracted by: Overholt)

 

Risk of bias score: LowK

 

Study objective:
To evaluate whether chlorhexidine gluconate gel dressing decreased the rate of major catheter-related infections (CR-sepsis with or without CRBSI [defined in Outcomes column]).

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
Intervention:
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:
  1. 1 or more positive peripheral blood cultures sampled immediately before or within 48 hrs after catheter removal;
  2. A positive quantitative catheter-tip culture (using 103 CFU/ml threshold when vortexing technique or 100 CFU threshold via sonication technique) for the same microorganisms(same species and susceptibility pattern) or blood culture differential time to positivity of 2 hrs or more; and
  3. No other infectious focus explaining the positive blood cultures (in patients with coagulase-negative Staphylococcus (CoNS), the same pulse-field gel electrophoresis patterns in catheter tip and blood cultures was required for a diagnosis of CRBSI).

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:

  1. Body temp ≥38.5°C or ≤36.5°C;
  2. Catheter colonization;
  3. Pus at insertion site or resolution of clinical sepsis after catheter removal (resolution of fever or hypothermia within 24 hrs before any change of antimicrobial therapy); and
  4. Absence of any other infectious focus.

 

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):
  • All catheter types:9/938 (1.0%) vs. 22/941 (2.3%); HR: 0.40 (CI: 0.19–0.87); p=0.02

CRBSI rate (events/1,000 catheter days):

  • All catheter types:0.5/1,000 vs. 1.3/1,000
  • CVCs: 0.6/1,000 vs. 1.6/1,000; HR: 0.30 (CI: 0.10–0.92); p=0.04
  • Arterial catheters: 0.5/1,000 vs. 1/1,000; HR: 0.51 (CI: 0.15–1.74); p=0.28

Major CRI incidence (events/patients):

  • All catheter types: 12/938 (1.3%) vs. 36/941 (3.8%); HR: 0.33 (CI: 0.17–0.62); p <0.01

Major CRI rate (events/1,000 catheter days):

  • All catheter types: 0.69/1,000 vs. 2.11/1,000
  • CVCs: 0.8/1,000 vs. 2.5/1,000;
  • HR: 0.27 (CI: 0.11–0.66); p=<0.01
  • Arterial catheters: 0.6/1,000 vs. 1.7/1,000; HR: 0.39 (CI: 0.15–1.03); p=0.06

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

Arvaniti, 20124
(Extracted by: Overholt)

 

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)

 

Inclusion criteria:
ICU patients over 18 years old who required a CVC for ≥3 days

 

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

 

Location: Greece

 

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

Intervention:
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
CRBSI:
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

Timsit, 20092
(Extracted by Overholt)

 

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

 

Location: France

 

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
  1. 1 or more positive peripheral blood cultures sampled immediately before or within 48 hrs after catheter removal;
  2. a quantitative catheter–tip culture testing positive for the same microorganisms or a differential time to positivity of blood cultures greater than or equal to 2 hrs; and
  3. no other infectious focus explaining the positive blood culture

Major CRI: either CR sepsis without BSI or CRBSI.

Catheter-related sepsis without BSI: combination of

  1. fever (body temperature over 38.5°C) or hypothermia (body temperature below 36.5°C);
  2. a catheter-tip culture yielding at least 103 CFUs/mL;
  3. pus at the insertion site or resolution of clinical sepsis after catheter removal; and
  4. absence of any other infectious focus.

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:

  • 8 patients (10.4/1,000 patients or 5.3/1,000 catheters) vs. NR
  • Contact dermatitis selectively affected very sick patients with multiple organ failure, subcutaneous edema, and fragile skin.

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

  • Organisms identified:
  • Intervention group: Enterococcus faecalis; Pseudomonas aeruginosa
  • Control group: E. faecalis; E. faecium; Providencia stuartii.

Ruschulte, 20093
(Extracted by: Overholt)

 

Risk of bias score: ModerateK

 

Study objective:
To investigate the effectiveness of a chlorhexidine dressing in reducing CRI

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

 

Location: Germany

 

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:
Insertion site: internal jugular vein or subclavian vein

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

Roberts, 19985
(Extracted by Overholt)

 

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 enrolled

Data 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

 

Dates: NR

 

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 catheters

C-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.

Footnotes

K       Basis of score described in Table 8.

L        Information obtained via correspondence with author.

References

  1. Timsit JF, Mimoz O, Mourvillier B, et al. Randomized controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing catheter-related infections in critically ill adults. Am J Respir Crit Care Med. 2012;186(12):1272-1278.
  2. 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.
  3. 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.
  4. 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.
  5. Roberts B, Cheung D. Biopatch–a new concept in antimicrobial dressings for invasive devices. Aust Crit Care. 1998;11(1):16-19.
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