You'd think that this would be a slam dunk of an argument: Good hand hygiene results in fewer surgical site infections. Case closed. End of story. Who would dare disagree that there's a correlation between SSIs and washing your hands, the most practiced ritual within today's ORs? Oddly enough, the evidence linking SSIs and surgical hand antisepsis is pretty thin, if it's there at all.

"Imagine conducting a study to correlate the two. Since SSIs are relatively rare, you would need a huge sample size," says Elaine Larson, RN, PhD, FAAN, CIC, professor of pharmaceutical and therapeutic research at Columbia University's School of Nursing in New York. "In addition, you would have to try to control for every other factor that might be related to SSIs, including other kinds of staff behavior, devices used and patient risk factors."

Alcohol or soap?
Dr. Larson points to one study that connects the dots from hand hygiene to SSIs. A paper published in the Journal of the American Medical Association in 2002 compared the efficacy and acceptability of agents used in surgical hand disinfection in three hospitals on 30-day SSI rates over a 17-month period.1 "Besides this," says Dr. Larson, "there really isn't that much out there."

The agents studied were aqueous detergent scrubs (either 4% povidone iodine or 4% aqueous chlorhexidine gluconate) and alcohol rubs. The protocol was to use aqueous detergents as traditional scrubs for at least five minutes and alcohol after a plain soap wash at the start of the day, as a hand-rub of two sequential 5ml applications with a total rubbing duration of five minutes. Excluding contaminated surgery, the surgical site infection rates were 2.48 percent (53/2135) in the scrubbing group and 2.44 percent (55/2252) in the hand-rub group. The difference between the groups was not significant. However, observation of duration of preparation showed better compliance when using alcohol than aqueous scrubs, and alcohol produced less skin dryness and irritation.

To be effective in practice, any hand hygiene procedure must not only produce a substantial kill or removal of contaminating micro-organisms but must also fit conveniently into routines, according to a critique of this study in Eurosurveillance Weekly.2 Although both the washing and alcohol handrub took 30 seconds, handwashing requires the individual to move to a sink and remain there throughout the process of using the handwashing agent, water, paper towels and disposal bin, says the critique.

A separate study found that handrubbing with an alcohol-based solution reduced bacterial contamination of healthcare workers' hands more than handwashing with antiseptic soap.3 Even though the study examined routine patient care activities at three intensive care units in a university hospital in France, its findings might be worth a look.

Twelve healthcare workers were allocated to handrubbing with a waterless alcohol-based solution and 11 were allocated to handwashing with antiseptic soap (chlorhexidine gluconate 4%). Researchers monitored patient care activities until a predetermined number of eligible activities (such as direct contact with a patient's skin before invasive care, after interruption of care and after contact with any part of a patient that was colonised with multiresistant bacteria) had been performed. When an opportunity for hand hygiene occurred, researchers took an imprint of the fingertips and palm of the participant's dominant hand before and one minute after the procedure. Gloves were removed before sampling.

In all, 114 patient care activities were performed (59 in the handrubbing group and 55 in the handwashing group). The median reduction in bacterial contamination was higher for participants in the handrubbing group (83 percent versus 58 percent, p=0.012). The groups did not differ for median time spent on hand hygiene.

"Handwashing is promoted as the single most effective means of preventing infections, but maintaining adherence to handwashing regimens has proved problematic," write Donna Moralejo, RN, PhD, associate professor at Memorial University School of Nursing in St John's, Newfoundland, Canada, and Andrew Jull, RN, MA, of the University of Auckland in Auckland, New Zealand, in a commentary on these two studies. "Hand rubs may be an alternative to handwashing, and the studies by Girou et al. and Parienti et al. add to the growing evidence about the effectiveness of handrubbing with alcohol-based solutions compared with standard hygiene methods."

The debate doesn't end there, of course. There's that variable known as "length of sustained activity." While alcohol provides excellent, immediate antimicrobial action, the duration of effectiveness is limited, write Graves and Twomey in their extensive evidence-based review of surgical hand antisepsis.4

"In outpatient surgical settings and in shorter-duration surgical cases in which typical cases may last less than 60 minutes, alcohol-based agents keep bacterial counts to acceptable level," write Graves and Twomey. "However, many institutions routinely do surgical procedures that last much longer."

There's also a variable known as "persistence." Tentative Final Monograph testing (in vitro) requires a demonstration of a product's efficacy up to six hours post-application (persistence), write Graves and Twomey. It's well established, they note, that that CHG detergent-based antiseptics and certain combination alcohol-based agents (alcohol plus a second FDA-approved agent) have the greatest persistence.

Other searches come up mostly empty
In February 2005, after the FDA went looking for published evidence linking surgical hand antisepsis to surgical outcomes and came up empty, it released a memorandum stating that the direct linking of surgical hand antisepsis to surgical outcomes is "conspicuously absent" in the published evidence.5 After reviewing more than 300 articles, "we were unable to perform a meta-analysis on the correlation of infection rates to microbiologic end points for surgical hand scrubs due to the variability in study designs and analysis and lack of information about study conduct in the published articles," reads the memo in part. In the end, the FDA concluded that it "found no data available on the correlation of microbiologic effects and hospital infection rates."

Part of the problem may lie in how the bactericidal activity of surgical hand antisepsis is measured. "Products for surgical hand disinfection may have equal microbial activity in suspension tests but show large differences under practical conditions," Marchetti and colleagues reported in a study comparing the bactericidal activity of five products used for surgical hand antisepsis.6

More troubling are the numerous studies that have found that none of the agents used in surgical hand scrub or antiseptic hand rub preparations ' alcohol, chlorhexidine gluconate, iodine and iodophors, parachlorometaxylenol, hexachloropene and quaternary ammonium compounds ' is a reliable sporicidal against Clostridium spp. or Bacillus spp. However, a 2005 abstract by Leischner and colleagues found that washing with chlorhexidine gluconate and water is more efficacious than alcohol-based agents in removing spores and vegetative bacteria.7 "This probably indicates that the physical action of hand washing/scrubbing is key to removing spores and vegetative cells," write Graves and Twomey.4

This matters little, however, if a surgical scrub doesn't last at least two to five minutes, which is what the CDC recommends. The AORN recommends that facilities have a "standardized protocol" that follows manufacturers' written instructions and is approved by the healthcare organization. When Girou et al. observed participants performing hand hygiene, a factor that may have improved compliance with hand hygiene, only 65 percent of handwashing procedures lasted more than 30 seconds, which is insufficient time to obtain optimum decontamination.2

Parienti et al. also examined compliance with time devoted to the two hand hygiene protocols in a subset of procedures.1 Adherence was poor in both groups, but similar to the findings of Girou et al., compliance was worse in the handwashing group (44 percent versus 28 percent). Many contend that the argument for no difference between protocols would be strengthened if SSI rates were similar when adherence to protocols was high. "While the study by Parienti et al. is an intriguing trial, whether hand rubs and handwashing are truly equivalent remains unclear," write Moralejo and Jull in Evidence-Based Nursing (2003;6:54).

"Overall, the findings of these [two] studies tend to support the conclusion that alcohol-based preparations are at least equivalent to, if not more effective than, traditional hand hygiene methods," they write. "Practitioners in all settings could use these studies as a basis for considering the introduction of alcohol- based hand rubs. However, before applying these findings, factors such as cost and clinician acceptance should be considered. Anecdotal reports of dermatitis and eczema being relieved when healthcare workers switched to alcohol-based rubs conflict with entrenched views that hand rubs are likely to increase such occupational hazards. If hand rubs are introduced, practitioners need to consider how they can best promote compliance with the new protocol and evaluate changes in nosocomial infection rates."

When is clean too clean?
Although the causal link between contaminated hands and infectious disease transmission is one of the best-documented phenomena in clinical science, says Dr. Larson, several factors have recently prompted a reassessment of skin hygiene and its effective practice.8

Widespread use of antimicrobial drug-containing products has raised concerns about the emergence of bacterial strains resistant to antiseptic ingredients such as triclosan.9,10 Some evidence indicates that long-term use of topical antimicrobial agents may alter skin flora.11,12 The question remains whether antimicrobial soaps provide sufficient benefit in reducing transmission of infection without added risk or cost, says Dr. Larson.

Damaged skin more often harbors increased numbers of pathogens. Moreover, washing damaged skin is less effective at reducing colonization than washing normal skin, and numbers of organisms shed from damaged skin are often higher than from healthy skin.13,14 In a recent survey, nurses with damaged hands were twice as likely to be colonized with S. hominis, S. aureus, gram-negative bacteria, enterococci, and Candida spp. and had a greater number of species colonizing the hands.15

Finnish investigators demonstrated that after frequent washing the hands of patient-care providers became damaged and posed greater risk to themselves and patients than if they had washed less often. A mild emulsion cleansing rather than handwashing with liquid soap was associated with a substantial improvement in the skin of nurses' hands.16

Dr. Larson reduces the argument to its simplest terms when she notes that some investigators have suggested that surgical hand antisepsis is required for the simple reason that surgical gloves sometimes tear during use and there's a risk of pathogens spreading from the practitioner's hands to the patient.

"There is a need for further clinical study showing cause and effect between the performance of surgical hand antisepsis and surgical site infections," write Graves and Twomey. "Although there appears to be an indirect link between [the two], via wound contamination, data are lacking to show a direct link to surgical site infections."4

References
1. Parienti JJ, Thibon P, Heller R, Le Roux Y, von Theobald P, Bensadoun H, et al. "Hand-rubbing with an aqueous alcoholic solution vs traditional surgical hand-scrubbing and 30-day surgical site infection rates. A randomised equivalence study." JAMA. 2002; 288: 722-7. (http://jama.ama-assn.org/issues/v288n6/rpdf/joc20200.pdf)
2. Eurosurveillance Weekly: 5 Sept. 2002;6(36).
3. Girou E, Loyeau S, Legrand P, et al. "Efficacy of handrubbing with alcohol based solution versus standard handwashing with antiseptic soap: randomised clinical trial." BMJ. 2002 ;325:362-5.
4. Graves PB and Twomey CL. "Surgical hand antisepsis: an evidence-based review." Perioperative Nursing Clinics. 1(2006)235-49.
5. Department of Health and Human Services (HHS)/Food and Drug Administration (FDA). Memorandum. "Nonpresciption Drug Advisory Committee Briefing Document: Effectiveness Testing Criteria for Healthcare Antiseptic Drug Products." 24 Feb. 2005.
6. Marchetti MG, Kampf G, Finzi G, et al. Evaluation of the bactericidal effect of five products for surgical hand disinfection according to prEN 12054 and prEN 12791. J Hosp Infect. 2003;54:63.
7. Leischner. Abstract #LB-29. Alcohol hand gel and C. difficile. ICAAC, 2005.
8. Centers for Disease Control and Prevention (CDC). "Hygiene of the Skin: When Is Clean Too Clean?" Emerg Infect Dis. 7(2), 2001.
9. Russell AD, Hammond SA, Morgan JR. "Bacterial resistance to antiseptics and disinfectants." J Hosp Infect. 1986;7:213-25.
10. APIC position statement. "The use of antimicrobial household products." APIC News. 1997;(Nov/Dec):13.
11. Ehrenkranz NJ, Taplin D, Butt P. "Antibiotic-resistant bacteria on the nose and skin: colonization and cross-infection." Proceedings from Sixth Interscience Conference on Antimicrobial Agents and Chemotherapy. Philadelphia: American Society for Microbiology. Antimicrob Agents Chemother; 1966. p. 255-64.
12. Bruun JN, Solberg CO. "Hand carriage of gram negative bacilli and Staphylococcus aureus." BMJ. 1973;2:580-2.
13. Ojajarvi J. "Effectiveness of hand washing and disinfection methods in removing transient bacteria after patient nursing." J Hyg (Camb). 1980;85:193-203.
14. Parry MF, Hutchinson JH, Brown NA, Wu CH, Estreller L. "Gram-negative sepsis in neonates: a nursery outbreak due to hand carriage of Citrobacter diversus." Pediatrics. 1980;65:1105-9.
15. Larson EL, Norton Hughes CA, Pyrek JD, Sparks SM, Cagatay EU and Bartkus JM. "Changes in bacterial flora associated with skin damage on hands of health care personnel." Am J Infect Control. 1998;26:513-21.
16. Lauharanta J, Ojajarvi J, Sarna S and Makela P. "Prevention of dryness and eczema of the hands of hospital staff by emulsion cleansing instead of washing with soap." J Hosp Infect. 1991;17:207-15.