Alcohol based hand rub vs.

traditional surgical scrub and the risk of wound infection: a randomized controlled trial.
Dr Mohammed Al Naami FRCSC,FACS,MEd. Dr Muhammad Farooq Afzal MD,FCPS,FRCSEd

Background

Drawbacks of traditional hand scrub with povidone or Hibiscrub

Mechanical trauma to skin(Kovach 2001) Dryness and irritation due to detergent nature.(Kikuchi 1999)

Drawbacks of using water

Splash, contamination,need to adjust temperature,leakage,cost

Can alcohol be a suitable alternative?

Alcohol is an established disinfectant. *Parenti et al have shown that no difference in the risk of wound infection when alcohol gel sterillium is used in comparison to traditional surgical scrub. Suitable in local circumstances as water is a scarce resource in the kingdom. But why the use of traditional method still popular?
Antisepsie Chirurgicale des mains Study Group. Hand-rubbing with an aqueous alcoholic solution vs traditional surgical

Hand-scrubbing and 30-day surgical site infection rates: a randomized Equivalence study. JAMA. 2002 Aug 14; 288(6): 722-7

Why alcohol gel is not used ?

Lack of convincing evidence.(no Meta analysis) Only one trial has published. Ethical Problem related to use of alcohol. Change???difficult

Study question
To determine the efficacy of alcoholic hand rub in the prevention of wound infection in clean surgery as compare to the traditional surgical scrub. Primary end point(dependent variable) Rate of wound infection Secondary end point Compliance,Skin tolerance

Protocol
Approval from Research and ethical committees and Infection control Informed consents from the patient Study design: a single blind randomized controlled trial
Randomization:Two groups for all eligible patients. In one group, the surgeon would use the traditional scrub method whereas in the second group the alcohol based hand rub would be used for hand disinfection before surgery. Randomization would be done using opaque sealed envelopes

Protocol.2
Blinding would be done by ensuring that those who look for the wound infection or interpret the microbiological results should not know the allocation group. Sample size: For a power of 80 and an alpha of 0.05,more than 4000 patients are required, Initially 250 patients with in each group(pilot study) Inclusion criteria: All patients undergoing clean and clean contaminated operations. All patients would be matched for confounders and would have same skin prep and drape method.
Exclusion criteria: Contaminated and dirty operation.

Methodology

Two groups would be made. One group would use the traditional three minutes method of scrubbing with povidone iodine or hibiscrub then washing with water The other group now using the 10 ml alcohol hand rub for hand disinfection without using water for one minute prior to OR. In case of soiling of the hands, washing would be done prior to use of alcohol hand rub.The composition of the alcohol rub is propanol-1,propanol 2 and mecetronium etilsulfate.(Purrrel TM).

Methodology..2
Tool for data recording: Two CRF(clinical report forms) Setting: OR of King Khalid university hospital Study enrollment: Feb 15,2006 to Aug 15,2006. Follow up: Patient would be followed up at one week and one month intervals from the day of operation

Methodology3

Wound infection would be defined according to the CDC definition of surgical site infection(CDC guidelines 1992) as: Increasing Pain,Redness or cellulites with discharge of pus from the whole or part of the wound with or without positive bacterial culture within 30 days of operation. Bacterial swab would be taken and culture and sensitivity would be done. Analysis Chi Square analysis for categorical variables using the SPSS 11.5.

References
1: Kovach TL. Maintaining intact skin during handwashing: the first line of defense against the chain of septic flow.J Pract Nurs. 2001 summer; 51(2): 21-5; quiz 26-7. 2: Kikuchi-Numagami K, Saishu T, Fukaya M, and Kanazawa E, Tagami H. Irritancy of scrubbing up for surgery with or without a brush. Acta Derm Venereol. 1999 May; 79(3): 230-2. 17: 3: Gruendemann BJ, Bjerke NB. Is it time for brushless scrubbing with an alcohol-based agent? AORN J. 2001 Dec; 74(6): 859-73. 4: Furukawa K, Ogawa R, Norose Y, Tajiri T. A new surgical handwashing and hand antisepsis from scrubbing to rubbing.J Nippon Med Sch. 2004 Jun;71(3):190-7.
5: Association of periOperative Registered Nurses Recommended Practices Committee. Recommended practices for surgical hand antisepsis/hand scrubs.AORN J. 2004 Feb; 79(2): 416-8, 421-6, 429-31. 6: Mulberrry G, Snyder AT, Heilman J, Pyrek J, and Stahl J. Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgicalscrub for antimicrobial efficacy.Am J Infect Control. 2001 Dec; 29(6): 377-82.

References
7: Herruzo-Cabrera R, Vizcaino-Alcaide MJ, Fdez-Acinero MJ. Usefulness of an

alcohol solution of N-duopropenide for the surgical antisepsis of the hands compared with handwashing with iodine-povidone and chlorhexidine:clinical essay.J Surg Res. 2000 Nov; 94(1): 6-12. 8: Pietsch H. Hand antiseptics: rubs versus scrubs, alcoholic solutions versus alcoholic gels.J Hosp Infect. 2001 Aug; 48 Suppl A: S33-6. 9: Rotter ML. Arguments for alcoholic hand disinfection. J Hosp Infect. 2001 Aug; 48 Suppl A: S4-8. 10: Mathias JM. Hand washing. Should we discard ritual of scrubbing with brush? OR Manager. 2000 Sep; 16(9): 20, 22.

References
11: Parienti JJ, Thibon P, Heller R, Le Roux Y, von Theobald P, Bensadoun H, Bouvet A, Lemarchand F, Le Coutour X; Antisepsie Chirurgicale des mains Study Group. Hand-rubbing with an aqueous alcoholic solution vs traditional surgical Hand-scrubbing and 30-day surgical site infection rates: a randomized Equivalence study. JAMA. 2002 Aug 14; 288(6): 722-7 12: Carr MP, Sullivan S, Gilmore J, Rashid RG. Preference and compliance of waterless hand-hygiene products versus soap and water. Am J Dent. 2003 Sep; 16 Spec No: 17A-19A.3. 13:Kampf G, Muscatiello M, Hantschel D, Rudolf M. Dermal tolerance and effect on skin hydration of a new ethanol-based hand gel.J Hosp Infect. 2002 Dec; 52(4): 297-301. 13: 14: Hobson DW, Woller W, Anderson L, Guthery E. Development and evaluation of a new alcohol-based surgical hand scrub formulation with persistent antimicrobial characteristics and brushless application. IS J Infect Control? 1998 Oct; 26(5): 507