CASE SCENARIO

A 40 yo female patient presents to urgent care with a three-inch laceration on her left calf. The sterile gloves available are too large for the provider at hand. There are fitting non-sterile gloves available. 

SEARCH QUESTION :

Does the use of non-sterile gloves in minor procedures (such as the suturing of small lacerations) present with greater incidence of infection in comparison to the use of sterile gloves?

QUESTION TYPE : 

Prevalence Screening Diagnosis

Prognosis Treatment Harms

Assuming that the highest level of evidence to answer your question will be meta-analysis or systematic review, what other types of study might you include if these are not available (or if there is a much more current study of another type)? Please explain your choices. 

If meta-analysis or systematic review are not available, I would expand my search to include retrospective cohort studies and randomized controlled trials. Alternatively, a randomized controlled trial may also be included. Patients may be randomly assigned to receiving a procedure with the use of non-sterile or sterile gloves to observe for procedure infection and adverse outcomes. The downside to using a randomized controlled trial in this PICO search is that the participants may not have been included based on the same research design or eligibility criteria. Factors such as coexisting medical complications of patients, variability in provider training and technique, and differences in laceration size  can dramatically influence and alter the data and conclusions. However, a strong design must be implemented at first to ensure that patients receive as close as possible treatment in sterile preparation, local anesthesia, surgeon performing the procedure, and patient post-operation education and wound care. This would allow for minimal bias and influence factors to ensure that the type of procedure performed is the factor assessed in the study.  

PICO SEARCH TERMS :

P	I	C	O
Laceration Patient	Non-Sterile Gloves	Sterile Gloves	Lower Infection Rates
Minor Injury Patient	Convention Gloves	Surgical Gloves	No Infection
Office Procedure Patient	Latex Gloves	Medical Gloves	Less Infection

SEARCH TOOLS & STRATEGIES USED :

Please indicate what databases/tools you used, provide a list of the terms you searched together in each tool, and how many articles were returned using those terms and filters. 

For this PICO search, I included systematic analysis, meta-analysis, and randomized controlled trials. I prioritized recent data along with the level of study to draw the most relevant and data-driven conclusion. Although RCTs are not the highest level of study, I believe it still yielded relevant and important data as the studies presented with contemporary research design, outpatient medical settings, and appropriate protocols. I found PubMed and JAMA to yield the best search results as it included several filters to specify search results. Google Scholar provided ample search results but with limited filter options. As a result, I had to manually review articles to search for appropriate studies to include in this PICO study as many results were not aligned with the clinical case scenario proposed. 

Database	Filter	Terms Searched	Articles Returned
PubMed	Meta- AnalysisSystematic ReviewCohort StudiesRCT2012 – 2022	Non-Sterile Gloves Minor Procedure	6
Surgical Glove Office Procedure	2
JAMA	Research ReviewSurgery	Non-Sterile Gloves Minor Procedure	26
Surgical Glove Office Procedure	30
Google Scholar	Review2012 – 2022	Non-Sterile Gloves Minor Procedure	316
Surgical Glove Office Procedure	2, 810

RESULTS FOUND :

Article 1 : The Necessity of Sterile Gloves for the Closure of Simple Lacerations

Citation: Steve E, Lindblad AJ, Allan GM. Non-sterile gloves in minor lacerations and excisions?. Can Fam Physician. 2017;63(3):217.

Type of Study: Systemic Review

Abstract: Lacerations are a common complication in the setting of acute and urgent care. Although current guidelines recommend the use of sterile technique, the use of sterile gloves is associated with increased costs and time. On the other hand, the use of non-sterile gloves may increase the risk for infection. This study aims to determine if the use of sterile gloves is necessary for uncomplicated procedures.

Methods :This study was performed in 2014 with a focus on patients who required sutures for minor lacerations.  The following databases were used to search for eligible studies :Ovid MEDLINEWeb of ScienceCinahlGoogle Scholar The following search terms were used :LacerationsWound InfectionHumansGloves Surgical 24 abstracts were screened and 12 were deemed eligible. Ultimately, 4 randomized controlled trials were included in this review with a focus on hand lacerations in an acute and urgent care setting.

Results :The following results are organized based on each of the 4 randomized control studies included in this systematic review : RCT 1Out of 402 patients who received a procedure with sterile gloves, 24/402 presented with infected wounds.Out of 396 patients who received a procedure with sterile gloves, 17/396 presented with infected wounds.RR 1.39 (0.76 – 2.55), Cl 95% RCT 2Out of 22 patients who received a procedure with sterile gloves, 10/22 presented with infected wounds.Out of 21 patients who received a procedure with sterile gloves, 3/21 presented with infected wounds.RR 3.18 (1.01 – 9.98), Cl 95% RCT 3Out of 121 patients who received a procedure with sterile gloves, 18/121 presented with infected wounds.Out of 121 patients who received a procedure with sterile gloves, 17/121 presented with infected wounds.RR 1.06 (0.57 – 1.96), Cl 95% RCT 4Out of 202 patients who received a procedure with sterile gloves, 35/202 presented with infected wounds.Out of 206 patients who received a procedure with sterile gloves, 36/206 presented with infected wounds.RR 0.99 (0.65 – 1.51), Cl 95%

Reason for Selection: This study was selected as it was a systematic review performed in 2014. This presents as a high level of study that was performed in recent years to provide relevant and current data. Furthermore, the study focused on minor laceration repair in an acute care setting and pertains to the clinical case study proposed.

Conclusion :This study showed that the use of surgical gloves did not decrease the incidence of wound infections. Furthermore, the use of surgical gloves increased medical costs. For this reason, the use of non-sterile gloves is deemed appropriate for patients with no significant risk factors for simple laceration repair. The study addresses that 2 of the 4 studies presented with limited quality as they presented with loss of follow-up and vague description of methodology.

Key Points:Surgical gloves increased medical costsSurgical gloves require more time for application during procedures Surgical gloves did not reduce infection rates for minor suturing procedures

Article 2 – Comparison of Sterile vs. Non Sterile Gloves in Cutaneous Surgery and Common Outpatient Dental Procedures

Citation: Brewer JD, Gonzalez AB, Baum CL, Arpey CJ, Roenigk RK, Otley CC, Erwin PJ. Comparison of Sterile vs Non Sterile Gloves in Cutaneous Surgery and Common Outpatient Dental Procedures: A Systematic Review and Meta-analysis. JAMA Dermatol. 2016 Sep 1;152(9):1008-14. doi: 10.1001/jamadermatol.2016.1965. PMID: 27487033.

Type of Study: Meta-Analysis

Abstract: In the outpatient setting, cutaneous surgical procedures are frequently performed. The use of gloves by providers was implemented over one-hundred years ago. Surgical gloves have been included in standard practice in the past few decades to limit rates of infection. However, this study aims to study if the use of sterile versus nonsterile gloves makes an impact on the development of postoperative site infection for minor outpatient surgical procedures. This would allow for the assessment of appropriate management of healthcare resources.

Methods :This study was performed in 2016 with a focus on patients who required sutures for minor lacerations. Two independent reviewers were used to screen for eligible articles. The following databases were used to search for eligible studies :Ovid MEDLINEOvid Cochrane Central Register of Controlled TrialsOvid EMBASEEBSCO Cumulative Index to Nursing and Allied Health LiteratureScopusWeb of Science The following search terms were used :Surgical GlovesDermatologic Surgical ProceduresSurgical InfectionsSterileCleanNon Sterile Outcomes were measured based on the following criteria:Wound Infection RatesTime of removal for suturesOther adverse outcomes 512 articles were initially considered. Ultimately, 14 articles met eligibility and were included in this study.  This included 11, 071 patients in the outpatient setting. 2, 741 of these patients received procedures were randomly assigned to the use of sterile or non-sterile gloves during a clinical trial. 8, 330 of the remaining patients specifically received outpatient cutaneous surgical procedures with sterile gloves (4, 680) and non-sterile gloves (3, 650).

Results : 2.5 % of patients who received procedures with non-sterile gloves experienced postoperative surgical site infection (R 1.06 (0.81 – 1.39), Cl 85%).0.9 % of patients who received procedures with sterile gloves experienced postoperative surgical site infection (RR 1.19 (0.81 – 1.73), Cl 85%).

Reason for Selection: This study was chosen as it was a meta-analysis performed in 2016. It presents as a high-level of study that was performed recently with detailed inclusion criteria. Furthermore, it included a large number of participants and a wider range of study types (randomized controlled trials, observational studies). This diversified the patient type and methodology of studies to provide a wide range of data with a more holistic perspective.

Conclusion : The study showed that there was no difference in rates of infection with the use of sterile versus non-sterile gloves for minor surgery performed in an outpatient setting.

Key Points:The use of sterile and non-sterile gloves presented with similar, low rates of postoperative surgical site infection2.5% of participants presented with infection with use of non-sterile gloves0.9% of participants presented with infection with use of sterile gloves

Article 3 – Comparing Non-Sterile with Sterile Gloves for Minor Surgery : A Prospective Randomized Controlled Non-Inferiority Trial

Citation: Heal C, Sriharan S, Buttner PG, Kimber D. Comparing non-sterile to sterile gloves for minor surgery: a prospective randomized controlled non-inferiority trial. Med J Aust. 2015 Jan 19;202(1):27-31. doi: 10.5694/mja14.00314. PMID: 25588441.

Type of Study: Randomized Controlled Trial

Abstract: Minor surgeries are inevitably prevalent in general practice (skin excisions, laceration sutures, wisdom tooth extraction, Mohs micrographic surgery). Previous studies performed in Mackay, Queensland showed a higher than expected incidence of surgical site infection in procedures performed with non-sterile gloves. The study aims to compare the incidence of infection after minor skin procedures with the use of non-sterile boxed gloves versus sterile gloves.

Methods :This randomized control trial was performed from 2012 – 2013 and included 493 participants. These patients were randomly allocated to minor procedures treated with non-sterile gloves (250) and sterile gloves (243). 6 doctors performed the operations with a previous history of successful wound management procedures. Two independent reviewers provided training to practice nurses to ensure that recording of data was standardized. Participants were eligible for this study based on the following inclusion factors :Presented for minor excision on any body site Participants were removed from this study based on the following exclusion factors :Taking any oral antibiotics during time of procedureImmunocompromisedSkin FlapsExcision of sebaceous cystHistory of latex allergy All procedures were standardized as on :Skin preparation with chlorhexidine solutionUse of sterile techniqueUse of local anesthesia subcutaneous injection 1% lidocaineClosure with nylon sutures using simple interrupted techniqueDressing application No application of topical or oral antibioticsPatient wound adviseRemoval Suture Time Outcomes were measured based on the following criteria:Wound Infection RatesTime of removal for suturesOther adverse Events

Results :Of the 493 participants, 15 patients were lost to follow-up.  8.7 % of patients who received procedures with non-sterile gloves experienced postoperative surgical site infection (RR 4.9 – 12.6, Cl 95%). 9.3 % of patients who received procedures with sterile gloves experienced postoperative surgical site infection (RR 7.4 – 11.1, Cl 95%). No other adverse events were found among participants.

Reason for Selection: This study was selected as a randomized controlled trial performed within the last 10 years. The study also included a very standardized procedure performed with adequate postoperative patient education on wound care. This ensured that there were minimal confounding factors that could influence the outcome of results.

Conclusion : This study suggests that the use of non-sterile boxed gloves is not inferior to the use of sterile gloves for minor excisions in general practice. Furthermore, the use of non-sterile gloves presented with savings in medical costs. Some limitations to this study included variations in suture size, surgical training and technique of providers, and subjective diagnosis of infection. A future study performed with one provider on patients presenting with similar laceration sizes would reduce confounding variables.

Key Points:8.7% of participants presented with infection with use of non-sterile gloves9.3% of participants presented with infection with use of sterile gloves$1.05 per glove was saved in using non-sterile gloves compared to sterile gloves

Article 4 – A Pilot Study on the Repair of Contaminated Traumatic Wound in the Emergency Departing Using Sterile Versus Non-Sterile Gloves

Citation: Ghafouri H, Zoofaghari S, Kasnavieh M, Ramim T, Modirian E. A Pilot Study on the Repair of Contaminated Traumatic Wounds in the Emergency Department Using Sterile versus Non-Sterile Gloves. Hong Kong Journal of Emergency Medicine. 2014;21(3):148-152. doi:10.1177/102490791402100303

Type of Study: Meta-Analysis

Abstract: The current standard of care for sterile procedures recommends the use of sterile gloves for surgical repairs. 3 – 5 % of wounds repaired in the emergency department presented with infection. Currently, the use of prophylactic antibiotics, irrigation, and sterile techniques are implemented to reduce the risk of infection. This study aims to study the use of nonsterile versus sterile gloves in suturing  contaminated laceration wounds (soil, small foreign bodies, animal bites) and its effects on surgical site infections.

Methods :This study was performed in 2010 on patients who presented to the emergency room in Tehran, Iran with contaminated soft tissue lacerations. Patients with any type of visible contaminated soft tissue lacerations were included in this study. Patients were then divided randomly into two groups, one receiving repair with non-sterile gloves and the other receiving repair with sterile gloves.  Studies excluded were based on the following criteria :Renal FailureImmunodeficiencyDiabetes MellitusLiver CirrhosisCurrent Use of antibioticsOpen FracturesConcomitant tendon, nerve or vascular injuryHuman and animal bites> 12 hours delayed presentationClinical signs of infection at presentation All patients were given Cephalexin antibiotics for 3 days. Postoperative data was collected 7 – 10 days after the procedure was performed during suture removal.

Results :  222 patients were included in this study. 36 of these patients were lost to follow-up. Overall infection rate was 3.2 %. 4.6 % of patients who received procedures with non-sterile gloves experienced postoperative surgical site infection. 2.02 % of patients who received procedures with sterile gloves experienced postoperative surgical site infection. The difference in infection rate between the two groups was not statistically significant (p = 0.322).

Reason for Selection: This study was chosen as it was a randomized controlled trial performed within the last 10 years. The study also included strong exclusion criteria to ensure that healthy patients presenting only with minor lacerations were included in this study.

Conclusion : The study showed that there was no difference in rates of infection with the use of sterile versus non-sterile gloves. However, factors such as small sample size, location of wounds, and variations in follow-up time could have presented as confounding factors in this study that influenced the data.

Key Points:4.6% of participants presented with infection with use of non-sterile gloves3.2% of participants presented with infection with use of sterile gloves

Weight of Evidence:

I would weigh Article 2 : Comparison of Sterile vs. Non Sterile Gloves in Cutaneous Surgery and Common Outpatient Dental Procedures as the strongest study. This is because it was a meta-analysis with the largest pool of participants. It presents as a high-level of study that was performed recently with detailed inclusion criteria. Furthermore, it included a large number of participants and a wider range of study types that diversified the patient type and methodology of studies to provide a wide range of data with a more holistic perspective. 

Next, I would select Article 1 The Necessity of Sterile Gloves for the Closure of Simple Lacerations as the next strongest study. This study presented as a systematic review that provided a detailed review of three randomized controlled trials. This presents as a high level of study that was performed in recent years to provide relevant and current data. Furthermore, the study focused on minor laceration repair in an acute care setting. This emphasized small laceration sizes in a uniform outpatient setting to assess the significance of using non-surgical versus surgical gloves.

I would then rank Article 3 Comparing Non-Sterile with Sterile Gloves for Minor Surgery : A Prospective Randomized Controlled Non-Inferiority Trial as the next strongest study. Although it was a randomized controlled trial and not considered as high a level of study as systematic review and meta-analysis, it included a very standardized procedural protocol to ensure participants were receiving the same care. 

Last, Article 4, A Pilot Study on the Repair of Contaminated Traumatic Wound in the Emergency Departing Using Sterile Versus Non-Sterile Gloves presents as the weakest study. This was a meta-analysis that included 222 participants. The study includes a much smaller pool of participants in comparison to the other articles. As a result, the participants may not provide a holistic sample size of the general public. Furthermore, the study did not outline specific inclusion and exclusion criteria to ensure that participants were eligible. 

What is the clinical “bottom line” derived from these articles in answer to your question?

The clinical bottom line is that the use of non-sterile gloves is appropriate in the setting of urgent care for minor laceration suturing procedures. The four studies concluded that risk for infection remained low with the use of non-surgical gloves. Furthermore, the application of non-surgical gloves required less time and reduced costs. This presents as an attractive, efficient, and highly reasonable medical practice for patients who present with small laceration, without significant risk factors, and who require fast treatment. For this reason, I would suggest that the use of non-surgical gloves in the patient presented in this clinical case scenario is appropriate. However, if the patient is immunocompromised or presents with foreign body or debris in the wound, I would recommend the use of sterile gloves during the procedure.