1. Disclosure: nothing to disclose
A Controlled Trial of Universal Gloving vs. Contact Precautions for Preventing the Transmission of Multidrug-Resistant Pathogens
G. Bearman, MD, MPH
A. Marra, MD
C. Sessler, MD
W.R. Smith, MD
R.P. Wenzel MD, MSc
M.B. Edmond, MD, MPH, MPA
Disclosure: nothing to disclose

2. Hypothesis
The effectiveness of universal gloving (use of gloves for all patient care activity) in preventing the transmission of multidrug-resistant pathogens will be greater than the effectiveness of contact precautions since compliance with universal gloving will be greater than compliance with contact precautions (gown and glove use).

3. Methods: Setting
12-bed medical ICU in an 820-bed, tertiary care, academic medical center
Closed-ICU staffing model with 5 attending intensivists

4. Study Design Methods: Phase I Phase II
Concurrent surveillance for nosocomial infections
VRE, MRSA surveillance cultures on admission & every 4 days
Measure hand hygiene compliance, antimicrobial usage
Contact precautions for VRE, MRSA colonized/infected pts
Universal gloving; no contact precautions

5. Methods: Surveillance
CDC/NNIS NI definitions used; surveillance performed by experienced ICPs
Hand hygiene observations performed by trained observers
Active microbiologic surveillance: nasal and rectal cultures obtained on all patients in the unit

6. Methods: Microbiologic Studies
One rectal swab culture for VRE and one nasal swab culture for MRSA performed on admission and every 4 days
Once a patient was culture positive, no further cultures were obtained for that organism
Pulse field gel electrophoresis (PFGE) for genetic typing and antibiotic susceptibility testing were performed on all MRSA and VRE isolates

7. Methods: Healthcare Worker Questionnaire
15 item survey was administered at the end of the study protocol
Target: MICU nurses and attending physicians
Focus:
self reported compliance with infection control practice
acceptability of universal gloving vs. standard of care

8. Methods: Additional Data Elements
Phase I vs. Phase II
Length of stay
MICU occupancy rate per month
MICU invasive devices utilization ratios
Nurse to patient ratio
Antibiotic usage: defined daily dose (DDD)

9. Results Variable Phase I Phase II P value Total patient days 1,090
1,377 -
Total observations for IC compliance
1,220
1,102
Total patients screened for VRE
192
257
0.54
Total patients screened for MRSA
228
301
0.60

10. Results: Hand Hygiene Compliance
Phase I
Contact Precautions
Phase II
Universal Gloving
Hand hygiene
N Obs %
P-value
Before patient contact
228
18.7
126
11.4
<0.001
After patient contact
704
57.7
578
52.5
0.011
A statistically significant reduction in hand-hygiene was observed in phase II

11. Greater adherence during universal gloving was observed
Results:
Compliance with Contact Precautions vs. Universal Gloving
Variable
Phase I
Phase II P N %
Compliance with gloving for patients on contact precautions
387
89.4
N/A
Compliance with gowns for patients on contact precautions
335
77.4
Compliance with gowns and gloves for patients on contact precautions
328
75.7
Total compliance: contact precautions vs. universal gloving
959
87.0
<0.001
Greater adherence during universal gloving was observed

12. Results: VRE screening
Variable
Phase I
Contact Precautions
Phase II
Universal Gloving
P value
Patients screened for VRE
192
257
Patients VRE positive upon admission to ICU
3 (1.5%)
3 (1.1%)
0.70
Patients with VRE conversion during ICU stay
39 (20%)
35 (14%)
0.31
Days to acquire VRE
(median) 8 9
0.79
No difference was observed in the rate of VRE acquisition

13. Results: MRSA Screening
Variable
Phase I
Phase II
P value
Patients screened for MRSA
228
301 -
Patients MRSA positive upon admission to ICU
11 (4.8%)
6 (2.0 %)
0.11
MRSA conversion during ICU stay
13 (5.7%)
15 (5.0%)
0.92
Days to acquire MRSA (median) 8 9
0.95
No difference was observed in the rate of MRSA acquisition

14. All MRSA conversions were with clonal or related isolates
Results: MRSA PFGE
MRSA
Phase I
Phase II
Number of strains 21 25
Conversion: negative to positive 13
13/13 clonal or related (100%)
Type A1, A2, A3, A4 15
15/15 clonal or related(100%)
Type A1, A5
PFGE types
A1: 13 (62%)
A2: 5 (23%)
A3: 1 (5%)
A4: 1 (5%)
B: (5%)
A1: 18 (72%)
A5: 2 (8%)
C: (12%)
D: (8%)
All MRSA conversions were with clonal or related isolates

15. Most VRE conversions were with clonal or related isolates
Results: VRE PFGE
VRE
Phase I
Phase II
Number of Strains 40 35
Conversion: negative to positive 39
20/40 clonal: (50%)
Type A, B
28/35 clonal (80%)
Type A, AA, AB
PFGE Types
Type A: 16 (34%)
Type B: 4 (11%)
Type D: 2
Type G: 3
Type H: 2
Type J: 2
Type K: 2
Types C,E,I, L,M,Q,R S,T: each
Type A: 18 (51%)
Type AA: 4 (11%)
Type AB: 4 (11%)
Type H: 2 (6%)
Types F,G,I,J,U,V,M:
1 each
Most VRE conversions were with clonal or related isolates

16. Results: Nosocomial Infections Rates
Outcome
Phase I
Phase II P
BSI/
1,000 catheter days
6.2
14.1
P<0.001
UTI/
4.3
7.4
Pneumonia/
1,000 ventilator days
2.3
A statistically significant increase in NIs was observed

17. Results: Nosocomial Infections
Phase I
Phase II
Infection #
Organisms
BSI 5
P. aeruginosa (1)
E. cloacae (1)
K. pneumoniae (1)
Prevotella spp (1)
C. glabrata (1) 16
Coag. negative staph (6)
Enterococcal spp (3)
VRE (1)
MRSA(2)
C. parapsilosis (1)
C. albicans (1)
UTI 6
E. coli (2)
C. albicans (3) 9
Coag. negative staph (1)
Enterococcal spp (1)
P. aeruginosa (2)
E. coli (1)
C. albicans (2)
C. non-albicans (2)
VAP NA 2
MRSA(1)

18. Results: Nosocomial Infections with VRE or MRSA
Phase I
Phase II
Infection
VRE
MRSA
BSI 1 2
UTI
VAP
4 infections with either VRE or MRSA were identified in Phase II

19. Results: MICU Additional Data
Phase I
Phase II
P value
Variable
5.3
6.8
0.07
Average length of stay (days)
87%
92%
0.36
MRICU occupancy rate/month
1:1.9 NS
Nurse to patient ratio
Device utilization ratio
Phase I
Phase II P
Urinary Catheter
0.85
0.87
0.83
Central line
0.74
0.72
Ventilator
0.56
0.62
0.47
Utilization ratio=device days/patient days

20. Results: Antibiotic Usage Defined daily dose (DDD/1000 patients-days)
Phase I
Phase II
P value
-lactams
391.6
352.9
0.075
-lactam/inhibitor
210.1
211.5
1.0
Aminoglycosides
68.2
118.2
<0.001
Glycopeptides
190.1
226
0.079
Metronidazole
127.0
118.6
0.582
Quinolones
385.7
359.0
0.206
Total
1372.7
1386.2
0.806
The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults
Example: DDD of levofloxacin is 0.5 grams, if 200 grams were dispensed in a period with 4,500 patient days: (200g/0.5g)/4,500 pt days X 1000= 89 DDD/1000 PD

21. Conclusions
Observed compliance with universal gloving was significantly greater than compliance with contact precautions (gowns and gloves).
However, greater compliance with hand hygiene was observed in the contact precautions phase.
No differences were detected between the two study phases for:
LOS, nurse/patient ratio, MICU occupancy rate, invasive device utilization, antibiotic usage

22. Conclusions
No differences in VRE and MRSA colonization were observed between the two study phases
In both phases, the majority of VRE and MRSA conversions were of a clonal or related isolate
However, an increase in nosocomial infection rates was observed during the universal gloving phase of the study
4 VRE/MRSA nosocomial infections were observed during the universal gloving phase

23. Conclusions
Although universal gloving was highly accepted by the staff, its implementation should proceed with caution given the observed increase in nosocomial infection rates
The use of universal gloving may have led to a misperception of decreased cross transmission risk
This may have lead to decreased hand hygiene compliance and a consequent increase in the rates of nosocomial infections

24. Conclusions Due to short study period (6 months):
The observed increase in nosocomial infections may have been a result of normal variation and may not have been attributed to the universal gloving intervention.

26. Criteria for PFGE interpretation
Category
# of Fragment Differences
Inferred relationship
Indistinguishable
Isolate represents the outbreak strain
Closely related
2-3
Isolate probably represents the outbreak strain
Possibly related
4-6
Isolate possibly represents the outbreak strain
Different
>7
Isolate is different from outbreak strain
Tenover et al.J.Clin Microbiol :