A Research Proposal For
“A comparison between hand contamination rates and the levels of environmental contamination when using different methods of removing gloves”
Title of project: A comparison between hand contamination rates and the levels of environmental contamination when using different methods of removing gloves
Abstract
Personal protective equipments (PPE) are recommended to provide optimal protection of cross infection among patients and Healthcare workers (HCW) when care of the infectious person. Gloves are necessarily to use in contact precaution for prevent transmitted infectious bacteria, virus and microorganisms, which spread by direct contact or indirect contact with infected person or contaminated environment. Bacteria and virus can be passed on to a HCW hands through invisible holes in the gloves or by contamination of hands during glove removal. Hence, there might be a chance of contamination and inducing the potential risk of getting infected by contact hands of HCW or their working environment.
This study focuses on the levels or areas of the hand and environmental contamination after doffing gloves. Fifty participants will be invited from an acute hospital to attend the study; each participant should perform a personal or causal doffing gloves method and a CDC removal gloves method after add Fluorescein solution onto their gloved hands. By using of Fluorescein stains as the contaminate of pathogens, testing the levels of contamination on hand and environment. The researcher will investigate and compare hand contamination rates and the levels of environmental contamination when using different methods of doffing gloves. This research study could be helped to understand the infection control measures in order to develop better practice and also enhanced to focus on environmental cleaning.
Objectives
The objective of the project is to compare the differences of hand contamination rates and the levels of environmental contamination associated with different glove removal methods.
Research Questions
1. What is the hand contamination rate in different glove removal methods?
2. What is the difference between the environmental contaminations in different glove removal methods?
3. What is the correlation between the hand contamination rate and glove removal methods?
4. What is the correlation between the environmental contamination and glove removal methods?
Hypotheses
Null Hypothesis: There is no difference between the levels and the rate of hand contamination and environment contamination when using different methods for removing gloves. .
Alternate Hypothesis: There is a change between the levels and the rate of hand and environment contamination when using different methods for removing gloves.
Background
The consequences of bioterrorism and the threat of emerging infectious diseases have become a reality for the frontline healthcare workers (HCW) (Chan 2007; Health Canada 2003; Seto 2003; Stein, Makarawo & Ahmad 2003; World Health Organization [WHO] 2006; WHO 2003). Personal protective equipments (PPE) are recommended to provide optimal protection of cross infection among patients and HCW (Stein et al. 2003; Seto 2003; WHO 2006; WHO 2003). Likewise, many studies have recognized that HCW may contaminate their hands or gloves when touching contaminated environmental surfaces and therefore causing their hands or gloves to become contaminated with a numbers of organisms that are likely to result in cross infection (Boyce 2007; Seto 2003; Doebbeling, Pfaller, Houstion & Wenzel 1988).
In fact, the Glove is one of the PPE items that is commonly used in clinical settings. Gloves are necessarily to use in contact precaution for prevent transmitted infectious bacteria, virus and microorganisms, which spread by direct contact or indirect contact with infected person or contaminated environment (Bhalla, Pultz, Gries, Ray, Eckstein, Aron, Donskey 2004). There are many cases related to Multidrug-resistant organisms (MDROs), Rota Virus, Norwalk Virus and Crusted (Norwegian) Scabies in clinical facilities (Hartstein, Pemry, Houstion, Wenzel 1988; CDC 2006 & Klevens, Edwards, Tenover, McDonald, Horan, Gaynes 2006). Contact Precautions also apply where the presence of excessive wound drainage, fecal incontinence, or other discharges from the body suggest an increased transmission risk (CDC 2006).
However, glove remains an ineffective protection to certain risks of infection (Hartstein, Pemry, Morthland, Lemonte & Pfalller 1995; Thompson, Dwyer, Ussery, Denman, Vacek & Schwartz 1997). Boyce & Pittet (2002) stated that Bacteria from patients were found on 30% of HCW hands who had worn gloves daily when in contact with a patient. Thus, Bacteria and virus can be passed on to a HCW hands through invisible holes in the gloves or by contamination of hands during glove removal (Boyce 2007; Boyce & Pittet 2002; Thompson et al. 1997; Marples, Towers 1979). Hence, there might be a chance of contamination and inducing the potential risk of getting infected by contact hands of HCW or their working environment.
Consequently, hand hygiene (HH) is the most important way to prevent and control the potential risk of infection transmission (CDC 2006; CDC 2002). Once this is controlled the potential risk of cross infection can be reduced (Infection Control Nurses Association 2002a). Therefore, some infection control measures of reducing the chance of contamination could be realized. Glove is an essential PPE for daily practices of healthcare staff, which is one of risk factors for poor adherence with HH (CDC 2006; CDC 2002). The chance of hand and environmental contamination could be reduced by controlling the method of glove removal. As a result, how to reduce the level of hand and environmental contamination by using of glove has become critical (Tenorio 2001). Besides, Areas which are identified as high levels of environment contamination should have advance daily cleaning procedures.
In view of this, this study focuses on the levels or areas of the hand and environmental contamination after doffing gloves. An intervention of doff gloves steps from Centres for Disease Control and Prevention (CDC) will be offered in-between the study by the investigator. All subjects should implement or adjust their glove removal technique according to CDC. The study is able to compare hand contamination rates and the levels of environmental contamination when using different methods of doffing gloves.
Subjects
A convenience sample of fifty frontline HCW of an acute hospital will be invited to attend the study, including nursing staff, healthcare assistants and doctors. According to Portney & Watkins (2000) mentioned in the paired t test table that the power is set at 0.8 (beta is 0.2) and the adopted alpha level is at 0.05 with medium effect size. Because of this power being set at 0.8 the probability of rejecting a null hypothesis is false. Historically, the range value of power set to 0.8, Beta 0.2; and alpha 0.05 has been used for calculating the sample size that is needed to achieve the power for an experiment. Besides, analysis of PASS 2008 under the Group-Sequential Logrank Tests , the total sample size of numbers is also calculated to 50 (appendix 1). Thus, 50 subjects will be collected in this study. Ethics approval should be applied before the study, and the experimental protocol should be approved by the Human Subject Ethics Sub-committee of The Hong Kong Polytechnic University. Besides, each subject was informed of the purpose and a procedure of the study as well as written consent was obtained beforehand. All participations were voluntary and subjects could withdraw at any time without any reason. Confidentiality and anonymity were also assured
Fluorescein solution and UV lamp
Fluorescein is a type of organic dye, in yellow colour and is safe to use as topical, oral, intravenous and retinal (Ford 1996). Many studies like to use Fluorescein stain to represent the contaminate of pathogens (Zamora, Murdoch, Simchison & Day 2006; Li, Wong, Chung, Gohel & Leung 2008; Li, Wong, Chung, Guo, Hi, Guan, Yao L, Song, Newton 2006; Wong, Chung, Chan, Ching, Lam, Chow, Seto 2004). Adverse reactions of Fluorescein includes nausea, vomiting, skin rash, acute hypotension, anaphylactoid reaction and cardiac arrest but report rates vary from 1% – 6% (Fineschi, Monasterolo, Rosi & Turillazzi 1999). Accordingly, a Fluorescein skin test is done on the inner part of the forearm on each subject before the study to make sure there is no allergic reaction. In this study, a Fluorescein solution is dilated from 0.5cc of a 25% solution in 100 cc of sterile water as a contaminate and then 5 cc of the Fluorescein solution is sprayed on each gloved palm (total 10cc are given both palms). Subjects will then be instructed to close both palms together with friction application for ten seconds
Fluorescein solution and ultra violet (UV) light detectable paste combine to form surrogate contamination. UV lamp is useful to detect the Fluorescein stain as it allows the invisible stained patch to become visible. The UV lamp machine might be checked and tested before the study takes place; same brand of machine is preferable from the start to the end of the study. This can prevent various results under distinct UV power. All participants need to be assessed with an UV lamp before donning the protective clothing in order to ensure that no Fluorescein is present..
Gloves
Latex disposable gloves will be selected in the test as it is a common material used by Hong Kong Hospital Authority. There are three general sizes: small, medium and Large. Disposable gloves are designed as a single-use medical tool which has invisible perforations that cannot provide complete protection against hand contamination (CDC 2002; Infection Control Nurses Association 2002b; Medicines and Healthcare products Regulatory Agency 2006). Each subject might be required to exam the integrity of the glove and double checked by the investigator before applying the Fluorescein solution. No leakage of gloves is allowed as it may affect the contaminated Fluorescein patch.
Preliminary test
A preliminary test to practise the method of photographing under the UV lamp in the dim or dark room will be done before the study. The preliminary test should check the successful results of Fluorescein patch shown on the photos and also estimate the number of sample size. 10% of total subjects are invited to attend in this test, and all of the experiment setting as well as equipments will be the same as the research study.
Experimental Protocol
This trial is an intervention study of experimental designs that allocates and compares the contamination level between subjects as well as carries out the intervention of CDC off gloves’ steps. The study is using a convenience sample plans collected from an acute hospital in Hong Kong; all subjects are frontline HCW who are working in clinical settings and familiar with using gloves in daily practices.
The fifty subjects will be invited to a private room that is kept between 22-25°C and at 70% humidity level, which is like their working environment in the hospital. Firstly, they will proceed with a skin test of Fluorescein solution and assess by an UV lamp as mentioned before. Then, they need to wear a suitable size of latex gloves, if there are no complaints or any allergy reactions. A disposable, nonwoven cloth gown will be provided and put on the subject, which enhances to serve as a unique absorption material for the Fluorescein patch and reduces influencing the result.
All subjects should stand on the measured point of the room that has designated footprints on the floor. The designated area is marked with USA shoes sizes 5 to 7 footprints. The study of environment contamination will be measured 2 feet from three sides of the subject (front, left and right). A rubbish bin will also be placed near the front wall for discarding the removed gloves. The 2 feet distance is according to the gown down area setting in this hospital. A total of 10 cc Fluorescein solution will be applied to each subject’s gloved palms and the subject is instructed to close both palms together with friction application for ten seconds afterwards. Then, the subject is allowed to doff the gloves off by casual or personal style. Photos will be taken of all the contaminated areas including bare hands, gown, rubber bin cover and walls under the UV lamp lighting in the dark.
A snack plus a bottle of distilled water will be offered after hand hygiene and a 30 minutes rest. During the resting time, the writer will present a video and demonstration of CDC’s recommended guidelines and methods on how to remove gloves. A demonstration of the CDC gloves removal method (figure 1) should be done by all the subjects after the break. Off gloves method of CDC is divided into 6 steps: 1. outside of gloves is contaminated; 2. grasp outside of glove with opposite gloved hand, peel off; 3. hold removed glove in gloved hand; 4. slide fingers of ungloved hand under remaining glove at wrist; 5. peel glove off over first glove & 6. discard gloves in waste container (CDC, 2003).
The implementations of CDC doff gloves method will be tested in Fluorscein solution when the subjects have passed the instructors pre-test of the CDC demonstration. A check list to record the important points of removing steps in CDC instructions might be acknowledged and verified (appendix 2). Subjects need to follow the instructions that eliminate any bias. Another set of photos will be taken afterwards. The work flow of paired Fluorsecein test is pointed out in figure 2.
Contamination
According to Zamora et al. (2006) study, the contamination stain will be measured in a Fluorescent patch size. A size larger than 1 square centimetre (cm²) is counted as a large patch (LP) and one smaller than 1 cm² is counted as a small patch (SP). Moreover, Squares of 30cm x 30cm will be marked on the white cloth which place on the walls of examination room that facilitating the calculation of Fluorescein patches on the photos. The Fluorescent patches might indicate the level of contamination.
Data analysis
This study describes the relation of the environment contamination formed by removing contaminated gloves and determines the difference between the levels of surrounding contamination after being introduced to an intervention of doffing gloves from CDC. However, the study also provides evidence to the impact of removing glove intervention in the current infection control practice. The data is analyzed by using SPSS 15.0 for windows, which calculates paired t test as the data is assumed to have normal distribution. Paired t test simply compares the two sets of data and identifies the results.
Figure 1. CDC recommendation on off gloves.
Time Planning
The researcher worked on the information collection and literature review over the past few months. For the recent month, finalizing the experimental setup was the most important issue and anticipating of the ethic approval from The Hong Kong Polytechnic University as well as reviewing the literature and gathering information. In the coming month, research volunteer (HCW) recruitment should start while the research topic and experimental setup is finalized. Furthermore, the preliminary test should be proceeded. Data collection procedures in the following three to six month, and commence the data analysis afterwards. The most effective way is to review the schedule periodically. Every semester a progress report of the research need to be submitted and a dissertation should be submitted at the end of semester four.
A preliminary work schedule:
References:
Bhalla A, Pultz N J, Gries DM, Ray AJ, Eckstein E C, Aron DC, Donskey CJ. 2004. Infect Control Hosp Epidemiol, 25:164-167.
Boyce JM. 2007. Environmental contamination makes an important contribution to hospital infection. J Hosp Infect, 65:50-54.
Chan P. 2007. Influenza-Asian Focus. Asia-Pacific Advisory Committee on Influenza, 2(3):3.
[CDC] US Centers for Disease Control. 2002. Guideline for Hand Hygiene in Healthcare Setting. Morbidity & Mortality Weekly Report, 51:1-56. [CDC] US Centers for Disease Control. 2003. Donning Personal Protective Equipment [Online]. Accessed on December 5, 2008. URL: http:// www.cdc.gov /ncidod/dhq/pdf/ppe/ppeposter148.pdf [CDC] US Centers for Disease Control. 2006. MDRO Guideline for Management of Multidrug-resistant Organisms in Healthcare Setting [Online]. Accessed on January 10, 2008. URL: http:// www.cdc.gov/ncidod/dhqp/gl_isolation_ contact.htmlDoebbeling BN, Pfaller MA, Houstion AK, Wenzel RP. 1988. Removal of nosocomial pathogens from the contaminated glove: implications for glove reuse and hand washing. Ann Intern Med,109:194-198.
Fineschi V, Monasterolo G, Rosi R, Turillazzi E. 1999. “Fatal anaphylactic shock during a fluorescein angiography”.Forensic Sci Int, 100(1-2):137-142.
Hartstein AI, Pemry MA, Morthland VH, Lemonte AM, Pfalller AM. 1995. Control of methicillin-resistant Staphylococcus aureus in a hospital and an intensive care unit. Infection Control and Hospital Epidemiology, 16(7):405-411.
Health Canada. 2003. Cluster of severe acute respiratory syndrome cases among protected health care workers – Toronto. Can Commun Dis Rep, 29:93-7.
Infection Control Nurses Association. 2002a. Protective Clothing: Principles and Guidance. Fitwise, Bathgate.
Infection Control Nurses Association. 2002b. Hand Decontamination Guidelines. Fitwise, Bathgate.
Klevens RM, Edwards JR, Tenover FC, McDonald LC, Horan T, Gaynes R. 2006. Clin Infect Dis, 42:389-391.
Li Y, Guo YP, Wong KCT, Chung WYJ, Gohel MDI, Leung HMP. 2008. Transmission of communicable respiratory infections and facemasks. Journal of Multidisciplinary Healthcare, 1:17-27.
Li Y, Wong TKS, Chung JWY, Guo YP, Hi JY, Guan YT, Yao L, Song QW, Newton E. 2006. In-vivo protective performance of N95 respirator and surgical facemask. Am J Ind Med, 49:1056-1065.
Marples RR, Towers AG. 1979. A laboratory model for the investigation of contact transfer of micro-organisms. J Hyg (Lond), 82:237–48.
Medicines and healthcare products Regulatory Agency. 2006. DB 2006 Single-use Medical Devices: Implications and Consequences of Reuse. Retrieved December 4, 2008, from www.m hra.gov.uk/home/idcplg?
Portney LG & Watkins MP. 2002. Foundations of Clinical Research: Applications to Practice. New Jersey: Prentice Hall.
Tenorio AR, Badri SM, Sahgal NB. 2001. Effectiveness of gloves in the prevention of hand carriage of vancomycin-resistant enterococcus species by health care workers after patient care. Clinical infectious Diseases, 32(5):825-829.
Thompson BL, Dwyer DM, Ussery Xt, Denman S, Vacek P, Schwartz B. 1997. Handwashing and glove use in a long-term care facility. Infection Control and Hospital Epidemiology, 18(2):97-103.
Seto WH, Tsang D, Yung RWH, et al. 2003. Effectiveness of Precautions against droplets and contact in prevention of nosocomial transmission of severe acute respiratory syndrome (SARS). Lancet, 361:1519-20.
Li Y, Wong TKS, Chung JWY, Guo YP, Hi JY, Guan YT, Yao L, Song QW, Newton E. 2006. In-vivo protective performance of N95 respirator and surgical facemask. Am J Ind Med, 49:1056-1065.
Marples RR, Towers AG. 1979. A laboratory model for the investigation of contact transfer of micro-organisms. J Hyg (Lond), 82:237–48.
Medicines and healthcare products Regulatory Agency. 2006. DB 2006 Single-use Medical Devices: Implications and Consequences of Reuse. Retrieved December 4, 2008, from www.m hra.gov.uk/home/idcplg?
Portney LG & Watkins MP. 2002. Foundations of Clinical Research: Applications to Practice. New Jersey: Prentice Hall.
Tenorio AR, Badri SM, Sahgal NB. 2001. Effectiveness of gloves in the prevention of hand carriage of vancomycin-resistant enterococcus species by health care workers after patient care. Clinical infectious Diseases, 32(5):825-829.
Thompson BL, Dwyer DM, Ussery Xt, Denman S, Vacek P, Schwartz B. 1997. Handwashing and glove use in a long-term care facility. Infection Control and Hospital Epidemiology, 18(2):97-103.
Seto WH, Tsang D, Yung RWH, et al. 2003. Effectiveness of Precautions against droplets and contact in prevention of nosocomial transmission of severe acute respiratory syndrome (SARS). Lancet, 361:1519-20.
Check List of CDC Recommended Doff gloves steps
Please þ when the steps are achieved.
1. Fingers should not touch the skin of your wrist when grasping the outside edge of the opposite gloved hand (step 1) ¨
2. Removed glove should be held in the ungloved hand (step 3) ¨
3. The ungloved finger should slide under the gloved wrist without touching
outer surface of the glove (step 4) ¨
4. One glove should be packed inside the opposite glove when both
gloves are removed
