Sterile versus non-sterile gloves

Sterile versus non-sterile gloves Sterile technique is generally used for laceration repair despite a lack of scientific evidence that this is necessary (Wilson, 2003). This study addresses whether there is a difference in the infection rate of lacerations randomised to receive repair using sterile versus nonsterile gloves. This will help to increase knowledge on the evidence of infection rates when nonsterile gloves are used. If it can be proven that the use of nonsterile gloves for laceration repair poses no risk, this could save time and have considerable financial savings. This may change clinical practise in the future. Research Question: Sterile versus non-sterile gloves: A safe alternative in the management of acute simple wounds in the pre-hospital environment? Sterile technique (including the use of sterile gloves) for acute simple wound or laceration management is traditional and the practise continues to be recommended (Wilson, 2003). However, there are few studies and little evidence to support this practise. Using clean nonsterile gloves rather than individually packaged sterile gloves for uncomplicated wound repair in the community may result in cost and time savings. Study objective: This proposal is for a prospective randomised controlled trial designed to determine whether there is a difference in the rate of infection, after suture repair of uncomplicated wounds and lacerations, using clean nonsterile gloves versus sterile gloves in a community setting. Justification: The research question separates this proposed study from in-hospital studies, and addresses the small data set available specific to community and pre-hospital environments (Perelman et al, 2004; Worral, 1987; Bodiwala George). Results will add to the body of evidence, broaden the knowledge base for the healthcare community and further the cause of science (Medical Research Council, 2010). This trial aims to provide quality data for publication, enabling informed re-use by others and thereby reducing the risk of data creation duplicity. Background: The Department of Health (DoH) (2005) paper Taking healthcare to the patient states that at least one million of the people taken to AE every year could be treated at the scene, in their homes or in the community. With the advent of the Emergency Care Practitioner (ECP) role, many simple wounds / lacerations are suitable for treatment and closure in the pre-hospital setting. During the year 2008 09, the National Health Service (NHS) reports that there were 663,475 Accident and Emergency attendances in England for lacerations, accounting for 8.5% of total attendances (NHS, 2010). Figures for the Ambulance service this trial will be run at show that over a six month period from April to September 2010, their ECPs attended 1555 calls for laceration / haemorrhage, 72.5% (n= 1127) of which were dealt with at the scene, negating a visit to an Accident and Emergency department. These wounds were cleansed, treated and closed where necessary using a variety of techniques from tissue adhesiv e to paper stitches or sutures. As sterile gloves are not available, the practitioner carrying out treatment of these wounds would have been using clean, non sterile gloves. This is in stark contrast to wound closure in the Accident and Emergency department where the use of sterile gloves is universal (NHS Clinical Knowledge Summaries, 2010). The question asked by this study is whether there is a difference in the rates of infection between wounds treated by practitioners wearing sterile versus non sterile gloves in the community. To answer this it is necessary to investigate what contributing factors to wound infection there are, how they are best managed and what, if any, difference gloves make to the control of infection. Pratt et al (2007) advise that best practice (in the absence of strong evidence) must be guided by expert opinion and national and international guidance; all of which should be integrated into local practice guidelines. In the case for use of sterile versus nonsterile gloves, there has been insufficient research to provide reliable evidence, therefore clinical tradition is followed and sterile gloves are the preferred choice. This dogmatic adherence to tradition is underlined by Flores (2008) who states Although ritualistic practice needs to be questioned, with the rising incidence of multi-resistant infections, it seems prudent to err on the side of caution when in doubt. Obviously then, it is important to remove the doubt by rigorous research into the area for concern, thereby adding quality data to the body of evidence and knowledge, and allowing this to steer best practise, however this is out of the scope of this study. Literature Review. A search of Cochrane Library gave 135 results, 1 of which directly answered the question (Perelman et al, 2004 see appendix one). A search of three other databases British Nursing Index (BNI), The U.S. National Library of Medicine premier life sciences database (PubMed) and Cumulative index to nursing and health literature Nursing allied health (CINAHL) revealed the same plus 2 others: Bodiwala George (1982) and Worral (1987) using the search term Infection OR Cross Infection OR Disease Transmission OR Infection Control AND Glove* OR Protective Device* OR Surgical Glove* OR Sterile Glove* OR Non Sterile Glove* AND Acute Traumatic Wound* OR Wound*.  LIMIT set to Human AND English. This shows there is little tangible research into the hypothesis suggested in this proposal. The prospective Randomized Control Trial (RCT) by Perelman et al (2004) in Canadian Emergency Departments compared sterile versus nonà ¢Ã¢â€š ¬Ã‚ sterile gloves (both latexà ¢Ã¢â€š ¬Ã‚ free) in sutured repair of lacerations. The study enrolled 816 patients (age à ¢Ã¢â‚¬ °Ã‚ ¥ 1) with blinding of patients and outcome assessors. Infection rates by 23 days were 4.3% in the nonà ¢Ã¢â€š ¬Ã‚ sterile group and 6% in the sterile group (no statistical difference), however credence was given to the possibility of skewing results due to the Hawthorne effect (Bowling, 2009) (As blinding the clinician in this type of study is impossible, it is possible that physicians using nonsterile gloves are simply more careful). This is the only RCT study of sterile versus nonsterile gloves. It is of high quality with a reasonable sample size, let down only by the non-standardised partially blind follow up. There are two older studies with significant limitations (comparing no gloves to sterile gloves) and questionable randomisation. Bodiwala George (1982) showed through their study of 408 patients that the difference in infection rates between gloved and ungloved suturing was not statistically significant. Worral (1987) found that infection rates were higher in the sterile gloved group, although the study group was small (n=50). Both these studies lend support to the idea that sterile gloves offer little in the way of reducing infection rates in the repair of simple lacerations, however suturing without any gloves is inappropriate and unsafe for practitioner and patient. Allan (2009) supports the findings of these earlier studies and concludes that present evidence indicates simple lacerations can be repaired with clean nonsterile gloves without an increased risk of infection. Acute traumatic wounds, in comparison to surgical incisions, are by their very nature already exposed to infective agents and the time delay between injury and treatment is longer (Forsch, 2008). Meticulous cleansing and where necessary, debridement is essential in reducing infection rates (Durham Hines, 2001). Moscati et al (1998) found that irrigation of acute traumatic wounds to remove grit, foreign bodies, dressing residue, excess exudates and other potential contaminants to be vitally important in preventing later complications of infection and tattooing. Generally it is agreed that wound cleansing by irrigation is preferable to swabbing or wiping (Dealey, 2005). Trott (2005) supports the old maxim The solution to pollution is dilution, stating that the most effective method for reducing bacterial load on wound surfaces and for removing debris and contaminants from within a laceration is through irrigation. This begs the question: if in the acute traumatic laceration a high bac terial load is already present, of what benefit are sterile gloves in their treatment and closure? Theoretical framework: This is a positivist paradigm (Parahoo, 2006), collecting scientific quantitative data. The research question is based on the empirical data from previous similar trials. It is acknowledged that empirical data is vulnerable to interpretation (Rubin Rubin, 2005) and this trial seeks to limit this by means of closed questions in the data gathering tool. The proposed study hypothesises that the use of clean nonsterile gloves when suturing acute simple lacerations in a community setting has little or no effect on post procedure wound infections. To refine the research question, guidance was taken from Lewith Little (2009) to ensure it is focused, is feasible and explicit. It is also a Statement of expectation relative to the variables investigated (Polit Beck, 2004). Research Methodology: This research will be a randomised controlled trial (RCT). This is chosen as there is a direct comparison between two variables; an RCT providing robust data. The RCT is the most appropriate method of study design, especially in the setting of wound repair, as suggestibility and patient expectations are potentially significant sources of bias (Jadad Cepeda, 2000). Although double blinding is impossible in this trial, the assessing clinician (data gatherer) will be blinded as to what gloves were used. However a weakness is acknowledged in that the patient may inform the assessing clinician and by so doing inject a risk of bias. To reduce the effect of other variables, ECP practise and equipment is standardised (Health Professions Council, 2010). All wound closure by the ECPs will comply with the most recent evidence based practise (NHS Clinical Knowledge Summaries, 2010). All cleaning materials, local anaesthetics and equipment are identical county wide, ensuring equality. Only mono-filament suture material will be used (no silks). Acknowledgement is given to the following variables over which this trial has no control: Individual client hygiene, poor compliance with wound care advice, further trauma to wound site post repair. The trial will be run over a six month period and utilise cluster randomisation by geographical area. For three months, sterile gloves will be used by ECPs in the west of the county whilst the east ECPs will use clean nonsterile gloves. At the three month point this will be reversed with west ECPs using clean nonsterile gloves and east ECPs using sterile gloves. Data will be collected by RW at the end of each week. Sampling: Randomised from the population area (east / west). Randomisation is automatic due to the nature of calls; assistance only being sought when needed by the public, therefore the study has no control over and cannot affect bias of patient, place, time etc. Only those calls attended by ECPs and deemed suitable for suture closure will be included. Limits: Inclusion: Patients over 18 years of age, who have sustained an acute, simple traumatic laceration which is less than six hours old requiring primary closure with simple, interrupted sutures. Exclusion: Patients with the following Very dirty / Tetanus prone wounds, immunocompromised, immunosuppressed, concomitant antibiotic use, deep wounds requiring layered suturing to eliminate dead space, puncture wounds, bite wounds (animal or human), any wound where there is suspicion of retained foreign body or damage to underlying structures, diabetes, wounds over 6 hours old. Data Collection: Data will be collected via post in the form of two clinician completed multi choice questionnaires at 3 days and at removal of sutures (ROS). The first interval gives a reasonable healing time for wound review and early identification of infection if present (patient safety). The second time interval was chosen as patients will need to re-present for this procedure and it gives reasonable opportunity for infection, dehiscence or other problems if present, to be apparent and acted upon as necessary. RW will be the dedicated researcher for collection of questionnaires, data analysis and telephone follow-up, (thus reducing response loss and attrition of data) at no cost to the trial. Patients will be supplied with 2 copies of the questionnaire as part of their discharge advice pack to facilitate continuity should they re-present at an earlier time for any reason, or at another facility. If the forms are not returned, telephone follow up will be done. As the patient should attend for wound review regardless of this research, completion of the questionnaire will cause minimal impact on clinician time, with little interference to departmental workloads. Questionnaires are designed to be simple and rapid to complete. All questionnaires will be supplied with a self-adhesive stamped self addressed envelope for ease of return. It is recognised that a limitation of this study is non return of questionnaires for whatever reason; this will be factored into the final statistical analysis. As it is impossible to blind the clinician as to whether the gloves are sterile or nonsterile in this trial, their input into it will be limited to indicating on the ECP form (See appendix 2) which group the patient fits into; A for sterile glove use, B for clean nonsterile. Randomisation and selection bias through allocation is avoided by the unpredictable nature of the emergency and unplanned workload covered by the clinicians (ECPs). This should help increase validity of findings (Bowling, 2009). As the division of the Ambulance service utilised for this trial is already divided into east and west areas, this will be used to control the intervention by allocation of sterile or nonsterile gloves. Initially, the west ECPs will use only sterile gloves for suturing wounds, with the east ECPs using clean nonsterile gloves. At the half way point in the trial, the researcher will reverse this. This allocation of gloves gives a reasonable control group from both sides of the county and acknowledges differences in individual ECP procedure, geography, demographics etc. Ethics: The four point biomedical ethics framework suggested by Beauchamp Childress (2001) has been considered in the design of this trial. This trial recognises autonomy for both patient and practitioner by seeking informed consent from participants. It promotes beneficence through its attempt to treat patients expeditiously, to high standards, without prejudice; and non-maleficence by reassuring participants that their data with be kept confidential. Justice is assured by equality of treatment for each participant. Ethical approval for the research will need to be sought from both the Ambulance service Clinical Review Group and University Ethics Committees prior to starting the research process. The researcher will be responsible for ensuring that the participants welfare is maintained. Consent will be sought by the attending ECP. Kimmel (2007) acknowledges that participants should come to no harm psychologically, physically or socially. By strict adherence to wound care guidelines (cleansing, dressing etc) in the acute assessment and treatment phase, and due regard for the patient during follow-up, this should be addressed. Consent: Prior to the study, education of ECPs through a micro-teach session (a 5 minute presentation) and poster campaign for those who cannot attend will be carried out. The ECPs will be asked if they will partake in the trial; there will be no expectation on them to do so and their inclusion will be purely voluntary. Informed consent will be sought from all patients although acknowledgement is given to the fact that the patient will be presenting in a post injury phase; they may be distressed, in pain and anxious. All patients participating in the trial will have a clear explanation given to them prior to discharge to ensure they fully understand their role and right to leave the trial at any point. Confidentiality: All data for publication, dissemination or public review will be purely statistical and numerical, having no personal details of the participants; there will be no breach of confidentiality. Participant safety: All prior research has concluded that there is statistically no difference in rate of infection when comparing glove use, adding support to the argument that there is little risk to the patient (Bodiwala, Worral, and Perelman). All gloves used will be latex free, reducing any risks of latex allergy / sensitivity to patient and clinician alike. All participants will have the opportunity to withdraw at any phase of the trial. Data Analysis and discussion: Data will be presented in a 22 contingency table (See appendix 4). As the research question is looking for a possible relationship between two variables, a bivariate statistical analysis will be used (See appendix 4). Specialist advice will be sought for the analysis of the statistical data. It is hoped that response rates will be very high as the respondent will be a medical professional (not the patient), the questionnaire is very short and straightforward, and is supplied with a self adhesive, stamped self addressed envelope. This scenario is similar to Perelamans experiment which achieved a 98% response. The patient, by the very nature of their injury, will need to attend for follow up / ROS. Calnan et al (2005) suggest a response rate of approximately 56% when reliant on the patient. Timeline: Year 2011 Initiate experiment 1st April Data collection Continuous and ongoing (RW) Complete fieldwork by 1st September Complete analysis by 1st October Give presentation on 8th October Complete final report by 1st November Conclusion: Sterile technique is generally used for laceration repair despite a lack of scientific evidence that this is necessary (Wilson, 2003). This study addresses whether there is a difference in the infection rate of lacerations randomised to receive repair using sterile versus nonsterile gloves. This will help to increase knowledge on the evidence of infection rates when nonsterile gloves are used. It is apparent that could it be proven that there is little evidence to support the continued use of sterile gloves; this could reflect a significant cost saving for the NHS (see appendix 5). This may change clinical practise in the future. References / Bibliography: Allan, M.G. (2009) Lacerations: Sterile Gloves Water? Tools for Practice. June 1, 2009. Beauchamp, T.L. Childress, J.F. ( 2001) Principles of Biomedical Ethics. New York: Oxford University Press. Bodiwala, G.G., George, T.K. (1982) Surgical Gloves During Wound Repair In The Accident And Emergency Department. The Lancet: July 10, 1982. pp 91-92. Bowling, A. (2009) Research Methods in Health (3rd ed), Maidenhead: Open University Press. Calnan, M., Wainwright, D., ONeill, C., Winterbottom, A. Watkins, A. (2005) Lay evaluation of health care: the case of upper limb pain. Health Expectations. 8(2):149-160. Dealey, C. (2005) The Care of Wounds (3rd ed). Oxford: Blackwell. Department of Health (2005) Taking Healthcare to the Patient: Transforming NHS Ambulance Services [online] Available at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4114269 Accessed 24/10/10. Durham C. Hines, S.E. (2001) Laceration assessment and management. Patient Care for the Nurse Practitioner. Jun; 4 (6): 17-20, 23. Flores, A. (2008) Sterile versus non-sterile glove use and aseptic technique. Nursing Standard. 23 (6) 35-39. Forsch,  R..  (2008). Essentials of Skin Laceration Repair.  American Family Physician.  78(8),  945-51.   Grava-Gubins, I., Scott, S. (2008) Effects of various methodologic strategies: survey response rates among Canadian physicians and physicians-in-training. Canadian Family Physician. Oct;54(10):1424-30. Hampton, S. (2003) Nurses inappropriate use of gloves in caring for patients. British Journal of Nursing 12(17):1024-7. Health Professions Council (2010) Standards of Proficiency. [Online] Available at http://www.hpc-uk.org/assets/documents/1000051CStandards_of_Proficiency_Paramedics.pdf Accessed 13/11/10 Jadad, A.R., Cepeda, M. (2000) Ten challenges at the intersection of clinical research, evidence-based medicine and pain relief. Annals of Emergency Medicine 2000;36:247-52. Kimmel A.J. (2007) Ethical Issues in Behavioural Research: Basic and applied Perspectives (2nd ed). Oxford: Blackwell. Lewith, G. Little, P. (2009) Randomised Controlled Trials in Saks, M. Allsop, J. (2009) Researching Health: Qualitative, Quanatitative and Mixed Methods. London: Sage. p 225. Medical Research Council (2010) Data Sharing Initiative: Aims. [Online] Available at www.mrc.ac.uk Accessed 09/11/10. Moscati, R.M., Reardon, R.F., Lerner, E.B., Mayrose, J. (1998) Wound irrigation with tap water. American Academy of Emergency Medicine. 1998; 5(11): 1076-80. National Health Service: Accident and Emergency Attendances in England (Experimental Statistics) 2008-09. Hospital Episode Statistics [online] Available at http://www.ic.nhs.uk/webfiles/publications/AandE/AandE0809/AE_Attendances_in_England%20_experimental_statistics_%202008_09_v2.pdf Accessed 24/10/10. National Health Service (2010) Clinical Knowledge Summaries: Lacerations Management. [Online] Available at http://www.cks.nhs.uk/lacerations/management Accessed 11/11/10. Parahoo, K. (2006) Nursing Research: Principles, Process and Issues. (2nd ed.) London: Palgrave-Macmillan. Perelman, V., Francis, G.J., Rutledge, T., Foote, J., Martino, F., Dranitsaris, G. (2004) Sterile versus Nonsterile Gloves for Repair of Uncomplicated Lacerations on the Emergency Department: A Randomized Controlled Trial. Annals of Emergency Medicine. 2004; 43(3): 362-370. Polit, D.F. Beck, C.T. (2004) Nursing research: Principles and methods. (7th ed.). Philadelphia: Lippincott, Williams Wilkins. Pratt, R.J., Pellowe, C.M., Wilson, J.A., Loveday, H.P., Harper, P.J., Jones, S.R.L.J., McDougall, C., Wilcox, M.H. (2007) epic2: National evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. Journal of Hospital Infections 65(Supplement): S1S64. Royal Mail [Online] available at http://www.royalmail.com Accessed 11/11/10. Rubin, H. Rubin, I. (2005) Qualitative Interviewing: The Art of Hearing Data (2nd ed.) London: Sage. Trott, A.T.(2005) Wounds and Lacerations: Emergency Care and Closure (3rd ed.) USA: Mosby. Wilson, J. (2003) Infection Control in Clinical Practice. (2nd edn.) London: Balliere-Tindall. Worral, G.J. (1987) Repairing Skin Lacerations: Does Sterile Technique Matter? Canadian Family Physician 1987; 33:1185-1187. Appendix 1 Relevant Paper Author, date and country Patient group Study type (level of evidence) Outcomes Key results Study Weaknesses Perelman et al 2004 Canada 816 patients over the age of 1yr old with simple lacerations prospective randomised controlled trial Infection post repair Infection rate for sterile vs non-sterile gloves was 6.1% and 4.4% respectively with no significant statistical difference partially blind follow up looking for signs of infection was not standardised Appendix 2 ECP information form Questionnaire 1 ECP No: Group A / B Incident No. Name: Age M / F Contact Tel. No: Site of laceration: Number and size of sutures: Appendix 3 Follow up Questionnaire Name: Age M / F Contact Tel. No: Is there any erythema extending à ¢Ã¢â‚¬ °Ã‚ ¥ 1cm from the wound? Y / N Is the wound hot to touch? Y / N Is the wound inflamed or swollen? Y / N Is there any purulent discharge? Y / N Does the patient report any increase in pain? Y / N If yes to any/all of above, is the patient systemically well? If no, refer immediately.