This paper will review a quantitative study comparing the outcomes of physicians that use sterile versus nonsterile gloves during simple soft tissue lacerations repairs in the Emergency Room. It will address the protection of human participants, their risks/benefits, and a review of the study’s data collection, data analysis, and problem statement along with an interpretation of its findings. Article
The article is from 2004, and was published in the Annals of Emergency Medicine. It’s entitled “Sterile Versus Nonsterile Gloves for Repair of Uncomplicated Lacerations in the Emergency Department: A Randomized Controlled Trial”. Protection of Human Participants
A random sampling of patients were taken from populations that presented to multi-center emergency rooms in the Toronto area, with simple soft tissue lacerations that required suture repair. Of the 1,100 people approached, 902 gave voluntary consent to participate in the study. Of those, 86 were excluded for a final total of 816. There were 245 patients who refused to participate, with 40% being children (the study enrolled any patient over the age of one). There was suggestion that the large amount of children who “refused” participation was related to “parental anxiety of entering their child into the study” (Perelman et al., 2004, p. 363). Specific physical, psychological, social or economic risks to patients were not addressed in this article, but a patient information sheet was given to participants before they signed the consent. The handout provided background information on wound management, infection, and the rationale for the study. There were no immediate or direct benefits for patients to be involved in this study. The protocol, patient consent form, and all other related information during this trial were reviewed and approved by the ethic and review boards of all facilities involved. Data Collection
Patients that arrived to one of three large community ER’s in the Toronto area, with a wound that was viewed to meet criteria, were provided written information on the rationale of the study and asked to participate. Inclusion criteria were addressed by a physician or resident that included assessing for complexity of laceration, location on the body, and if it had occurred within 3 hours from patient’s arrival. A signed a consent was obtained and data was collected through completion of a checklist noting the patient’s age, sex, site of laceration, type of injury, time of injury, time of injury from the time of repair, and technique of repair. The patient was given a self-addressed, pre-stamped envelope that was to be completed by the physician who took the sutures out.
This physician filled out an explicit questionnaire using specific guidelines on wound assessment (pus, erythema, fever,) their clinical impressions (infection vs. no infection), and their management plan (topical/oral/IV antibiotic use, or need for referral to wound specialist). The follow up physician was unaware of which gloves were used in initial repair of the wound. The returned questionnaires where coded to collate with the initial assessment forms. There are several independent and dependent variables in this study. They include: not being able to run an equivalency trial related to the large sample size of the study, and the study was only partially blind (blind to the patients, not the physicians) because the sterile and nonsterile gloves are packaged differently.
Also, the study could not 100% standardize the technique of wound repair by the physicians, although they did receive orientation on “ideal” wound repair techniques with irrigation, and a there was not a single follow up clinic site that could have provided more standardization in the evaluation of wound assessment during the follow up visit. No time period for data collection was specified in this article. Data Management and Analysis
Statistical software was used in the analysis of data retrieved during this study. “Demographic and clinical data were presented descriptively as means, medians, or proportions with SDs where appropriate. The χ2 test was used to compare differences in infection rate between the 2 glove groups. A 2-tailed P value less than .05 was considered significant” (Perelman et al., 2004, p. 364). There were 4 discrepancies noted in the data between the objective wound assessments and the follow up clinicians notions of the wound, with (2) being clarified by the researchers with the documenting physician, and the remaining 2 were placed in the “infected group”. Findings/Interpretation of Findings
The researchers found that there is clear evidence to support that nonsterile gloves can be used in place of sterile gloves for simple laceration repairs in the Emergency Department, without an increase in wound infections. This writer believes that the findings are valid for several reasons. One, this study cites other previous studies that had similar outcomes in related topics such as: using tap water for cleaning/irrigating wounds, or the absence of gloves, caps or masks did not affect wound infection outcomes. Secondly, this has already become practice for many physicians in the United States. This is supported in the article by researchers when a preliminary survey of 18 ER physicians and 24 PCP showed 70% often used nonsterile technique in their repairs.
Lastly, the study showed comparative infection rates of 6.1% for sterile glove use and 4.4% nonsterile glove use with a level of significance of 0.05. Limitations were defined above as variables. Implications for nursing are two-fold. One, nurses can help support this nonsterile technique and continue to ensure good wound cleansing and irrigation of wounds. Using this techniques can save hospitals up to $2000/year in ER’s that see an average of 10 suture repairs/day. Secondly, as previously mentioned, this study cites others that address wound care (ex: irrigating with tap water vs. sterile saline), so this research can be used in the future to study methods of successful wound management for nursing. Conclusion
In conclusion, this was a successful study in showing that there was no increase in wound infections when nonsterile gloves are used while repairing simple lacerations in the Emergency Department. It is also showed that there can be economical savings for health care entities.
Grand Canyon University [GCU]. (2011). NRS433V.v10R research critique, part 2. Retrieved from: https://lc-ugrad1.gcu.edu Perelman, V. S., Francis, G. J., Rutledge, T., Foote, J., Martino, F., & Dranitsaris, G. (2004, March). Sterile versus nonsterile gloves for repair of uncomplicated lacerations in the Emergency Department: A randomized controlled trial. Annals of Emergency Medicine, 43, 362-370. http://dx.doi.org/10.1016/j.annemerged.2003.09.008
Courtney from Study Moose