Issue: Alcohol-based sanitizers (ABS) have been in widespread use for

several decades, and recommended by the CDC for use in hospitals since

2002. However, even with the addition of ABS to hospitals, the CDC esti-

mates that approximately 5% of patients will contract a hospital-

acquired infection (HAI) during their stay, resulting in nearly 99,000

deaths annually.

Project: To provide a complete and detailed review of all controlled

clinical studies in hospitals comparing nosocomial infection rates be-

tween handwashing alone and handwashing with the addition of an

ABS. Studies with additional interventions, such as a complete educa-

tion program, were not included. A total of six studies were identified

meeting these criteria, published between 1992 and 2008. Control

products varied, including CHG, PCMX, and iodine-based handwashes.

The protocols also varied widely, with some studies providing extra edu-

cation to the experimental group that was not given to the control group

or providing patients themselves with additional hand hygiene products

in the experimental group.

Results: Two of the six studies showed a reduction in HAIs with the ad-

dition of an alcohol sanitizer, three studies showed no additional benefit,

and one study showed that the addition of alcohol sanitizers significantly

increased nosocomial infections. The only two studies where alcohol

showed a benefit were conducted with a PCMX control and were not

crossover studies. In one of the studies where the authors concluded no

difference, the raw data showed a 27% increase in HAIs with alcohol. In

another, alcohol increased infections over the baseline in 4 of 6 catego-

ries studied. There was also a noted difference between studies con-

ducted in ICUs, which showed increased infection rates with ABS rubs,

and surgery centers and outpatient facilities.

Discussion: Alcohol sanitizers have not been conclusively demonstrat-

ed to reduce HAIs over handwashing alone, and have never shown supe-

riority over a top-tier handwash or in a crossover study. The failure to

reduce HAIs, in spite of increasing compliance, may be due to the lack of

persistent activity. As the FDA Monograph states, “Persistence, defined

as prolonged activity, is a valuable attribute that assures antimicrobial

activity during the interval between washings, and is important to a safe

and effective healthcare personnel handwash”

Author Year Control Product Crossover Facilities Number of Patients Sponsor Potential Confounding Factors Results

Doebbeling B, Stanley G, Sheetz C, et al1 1992 CHG (4%) 3 ICUs 1,894 Calgon-Vestal None reported Increase of 33.4% in HAIs

Larsen E, Cimiotti J, Haas J, et al2 2005 CHG (2%) 2 NICUs 2,932 3M Avagard Difference in average birth weight and number of intuba-

tions among control and experimental groups. Increase of 27.3% in HAIs

Parienti J, Thibon P, Heller R, et al3 2002 Povidone iodine (4%) or

CHG (4%)

6 Surgery

Centers 4,387 Rivardis Labs None reported No difference found in HAIs

Rupp M, Fitzgerald T, Puumala S, et al4 2008 PCMX (0.3%) 2 ICUs Unreported GOJO None reported No difference found in HAIs

Fendler E, Ali Y, Hammond B, et al5 2002 Not reported, assumed

to be PCMX(0.3%)

Extended

Care Facility Unreported GOJO

1.All community facilities (“offices, cafeteria, activity center,

rehabilitation area, dialysis unit”) in control group.

2.Patients in experimental group “differed in their level of

acuity”, having subacute conditions and higher turnover,

control group had chronic conditions and low turnover.

3.Staff/Patient ratio significantly differed between control

(1:4.5) and experimental (1:8.5) groups

Reduction of 30.4% in HAIs

Hillburn J, Hammond B, Fendler E, et al6 2003 PCMX (0.3%)

Orthopedic

Surgery

Suite

Unreported GOJO

1. Patients in experimental group given individual bottles of

hand sanitizer.

2.“Promotional campaign” for experimental group, includ-

ing in-service, posters, informational brochures to patients.

3.Monthly feedback to staff in experimental group. “An

awareness of this information may have helped affect the

reduction of infections.”

Reduction of 36.1% in HAIs

Impact of alcohol sanitizers on hospital-acquired infections: A review of hospital clinical trials.

Stanley Jacob, MD; Colette Cozean, PhD; Jesse Cozean

Stanley Jacob, MD, has nothing to disclose. Colette Cozean, PhD, and Jesse Cozean are paid consultants with Innovative BioDefense, Inc.

Change with Alcohol Sanitizer

UTIs 40.0% increase

Skin Infections 93.0% increase

GI Infections 43.6% increase

Overall 33.4% increase

Change with Alcohol Sanitizer

Bloodstream 23.0% increase

Pneumonia 29.4% increase

Skin Infections 77.4% increase

Central Nervous

System Infections

6.0% increase

Conjunctivitis 15.8% decrease

Overall 27.3% increase

Two studies1,2 reported specific results for different

kinds of infections, as well as an overall result of add-

ing an alcohol sanitizer. Both reported significant in-

creases in many categories, including skin infections

(93%, 77%) as compared to a CHG cleanser, and a

large overall increase in HAIs with the addition of ABS.

Conclusion

The four crossover, well-controlled studies either showed an increase in

HAIs or no difference when compared with handwashing alone. This

supports a study sponsored by the CDC, which showed medical facilities

that rely on alcohol sanitizers are six times more likely to have an illness

outbreak.7

While alcohol-based sanitizers may be more convenient than soap-and-

water washing and increase compliance, the scientific literature reviewed

does not show a reduction in infection rates with the addition of an

alcohol sanitizer.

1. Doebbeling BN, Stanley GL, Sheetz CT, et al. Comparative efficacy of alternative handwashing agents in reducing nosocomial infections in intensive care units, New England Journal of Medicine, 1992; 327: 88-93

2. Larson E, Cimiotti J, Haas J, et al. Effect of antiseptic handwashing vs alcohol sanitizer on health care-associated infections in neonatal intensive care units. Arch Pediatr Adolesc Med. 2005; 159(4): 377-83

3. Parienti J, Thibon P, Heller R et al. Hand-rubbing with an aqueous alcoholic solution vs traditional surgical hand-scrubbing and 30-day surgical site infection rates, a randomized equivalence study, Journal of the American Medical Association, 2002, 288(6): 722-7

4. Rupp M, Fitzgerald T, Puumala S et al. Prospective, Controlled, Cross‐Over Trial of Alcohol‐Based Hand Gel in Critical Care Units, Infection Control and Hospital Epidemiology. 2008; 29:1

5. Fendler E, Ali Y, Hammond B et al. The impact of alcohol hand sanitizer use on infection rates in an extended care facility, American Journal of Infection Control. 2002, 30:226-33

6. Hillburn J, Hammond B, Fendler E et al. Use of alcohol hand sanitizer as an infection control strategy in an acute care facility. American Journal of Infection Control. 2003, 31:109-16

7. Blaney D et al, Use of alcohol-based hand sanitizers as a risk factor for norovirus outbreaks in long-term care facilities in northern New England: December 2006 to March 2007, American Journal of Infection Control, 39 (4) 296-301, 2011

Results from Doebbeling et al

Results from Larsen et al