Doel van deze module is het beschrijven wanneer het gebruik van niet-steriele handschoenen bijdraagt aan het (doelmatig en kosteneffectief) verkleinen van de kans op transmissie van micro-organismen via en/of naar medewerkers. Hierbij wordt aandacht besteed aan indicaties voor gebruik van niet-steriele handschoenen op basis van de eigenschappen van deze middelen conform wet- en regelgeving (zie module wet- en regelgeving).

De huidige praktijk van gebruik van niet-steriele handschoenen is ontstaan zonder dat voorafgaand studies zijn gedaan naar de effectiviteit en indicaties. Eerder werden niet-steriele handschoenen met name gebruikt in contact met patiënten met specifieke infectieziekten. Met de opkomst van de hiv-epidemie is het gebruik toegenomen bij alle zorghandelingen waarbij contact met lichaamsvloeistoffen, slijmvliezen of niet-intacte huid waarschijnlijk is (zogenaamd Body Substance Isolation). Deze praktijken zijn vastgelegd in internationale (WHO 2002, CDC 2019) en nationale richtlijnen.

Het dragen van steriele handschoenen (worden niet gedragen als persoonlijk beschermingsmiddel) evenals het dragen van niet-steriele handschoenen om de besmetting met radioactieve of toxische stoffen te voorkomen valt buiten de scope van deze module.

Description of studies

Alhmidi & Cadnum (2021) conducted an observational study and aimed to determine whether the use of gowns adds a substantial benefit over gloves alone in preventing patient-to-patient transfer of a viral DNA surrogate marker. In total, 30 source patients had 1 cauliflower mosaic virus surrogate marker applied to their skin and clothing and a second to their bed rail and bedside table. Personnel caring for the source patients were randomized to wear gloves, gloves plus cover gowns, or no barrier. Interactions with up to 7 subsequent patients were observed, and the percentages of transfer of the DNA markers from patient-to-patient were compared among the 3 groups.

Alhmidi & Li (2021) conducted an observational study in which simulated patient care interactions were performed to evaluate the efficacy of different types of barrier precautions and to identify routes of transmission. In randomly ordered sequence, 30 personnel each performed 3 standardized examinations of mannequins contaminated with pathogen surrogate markers (cauliflower mosaic virus DNA, bacteriophage MS2, nontoxigenic Clostridioides difficile spores, and fluorescent tracer) while wearing no barriers, gloves, or gloves plus gowns followed by examination of a noncontaminated mannequin. The percentages of transfer of the DNA markers from patient-to-patient were compared among the 3 groups.

Harris (2021) conducted a randomized trial to study the effect of universal glove and gown use on the acquisition of antibiotic-resistant gram-negative bacteria. This was a secondary analysis of a randomized trial in 20 hospital intensive care units (BUGG study). ICUs were randomized to either the intervention or control arm. During the baseline period, all ICUs followed their usual standard of care, which consisted of healthcare workers following CDC contact precautions guidelines (gloves and gowns) for patients known to have antibiotic-resistant bacteria such as VRE and MRSA. After the baseline period, ICUs were randomized, and during the study period, all healthcare workers (nurses, physicians, respiratory therapists, etc.) in the 10 ICUs assigned to the intervention arm were required to wear gloves and gowns for all patient contact and when entering any patient room. The 10 control ICUs followed their usual standard of care during the study period. All patients had ICU admission and ICU discharge perianal cultures. The primary outcome was acquisition of either carbapenem-resistant Pseudomonas aeruginosa, carbapenem resistant A. baumannii, ESBL-producing Enterobacteriaceae, or CPE as a composite of any antibiotic-resistant gram-negative bacteria based on surveillance cultures. A total of 40 492 admission and discharge perianal swabs from 20 246 individual patient admissions were included. Compliance with wearing gloves in the intervention ICUs was 86.18% (2787 of 3234), and compliance with gowns was 85.14% (2750 of 3230). In the control group, 10.52% of patients were on contact precautions. In the control ICUs, for patients on contact precautions, compliance with wearing gloves was 84.11% (556 of 661) and compliance with gowns was 81.21% (536 of 660).

Chang (2019) conducted a systematic review and meta-analysis to study the effect of universal gloving on healthcare-associated infections (HAIs). A systematic search of Ovid MEDLINE, Cochrane Library, Web of Science, EMBASE, and ClinicalTrials.gov was conducted in July 2018. Studies were included if they met the following criteria: (1) healthcare-associated infection was the reported outcome (including but not limited to MRSA, VRE, C. difficile), (2) the intervention being studied included universal gloving during patient care for all patients on that unit regardless of colonization or infection, (3) the study was either a randomized controlled trial, a nonrandomized quasi-experimental study, or an observational study. Studies were excluded if the investigators did not distinguish between universal gloving in the intervention group versus the control group (eg, having universal gloving in both groups), and all studies concerning interventions implemented because of outbreaks were excluded. Eight studies were included in review (4 RCTs, 4 before-and-after quasi-experimental studies). Four studies described the use of gloves only as an intervention, two studies gloves and gown combined and two studies a larger bundle of interventions. Three studies reported the incidence of MRSA and vancomycin-resistant enterococci (VRE) only, two reported the incidence of MRSA, VRE, and an additional infection type, and the remaining 3 studies reported the incidence of all HAIs.

Results

Because of large heterogeneity (comparisons, settings, definition of outcome measures), between the included studies a meta-analysis could not be performed, and the results of the included studies are described separately.

Transmission of microorganisms (transmission to healthcare worker, transmission from patient to patient, contamination of clothing with microorganism)

Comparison gloves versus no gloves

Alhmidi & Cadnum (2021) compared gloving as a stand-alone intervention with no barrier in preventing patient-to-patient transfer of a viral DNA surrogate marker. In comparison to the no-barrier group (57.8% transfer), transfer of 1 or both markers occurred less often in the gloves group (31.1%; OR=0.15; P = .007).

The frequency of contamination of personnel hands and clothing was higher in the no-barrier group (19 of 29 personnel assessed, 65.5%) than in the gloves group (14 of 27 personnel assessed, 51.9%) but the differences were not statistically significant (P > .05).

Alhmidi & Li (2021) compared gloving as a stand-alone intervention with no barrier to detect routes of transmission of a surrogate marker performing examinations on mannequins. Transfer by hands occurred in a smaller proportion of observations in the gloves-alone group (OR=0.02; P = 0.001) versus the no-barriers group.

Stethoscope transfer occurred frequently when no barriers were worn (30% for C. difficile spores, 47% for MS2, and 66% for fluorescent marker), stethoscope transfer also occurred ≥17% of the time for C. difficile spores and MS2 and ≥33% for fluorescent marker when gloves were worn. Two of 30 participants (6.7%) transferred at least 1 marker to the environment in the glove group versus 19 of 30 subjects (63.3%) in the no-barrier group (significantly lower).

Comparison gloves and gowns versus no gloves and gowns

Alhmidi & Cadnum (2021) compared the use of gloves and gowns combined with no barrier in preventing patient-to-patient transfer of a viral DNA surrogate marker. In comparison to the no-barrier group (57.8% transfer), transfer of 1 or both markers occurred less often in the gloves-plus-gown group (25.9%; OR=0.10; P =0 .002).

The frequency of contamination of personnel hands and clothing was higher in the no-barrier group (19 of 29 personnel assessed, 65.5%) than in the gloves plus-gown group (13 of 27 personnel assessed, 48.1%), but the differences were not statistically significant (P > 0.05).

Alhmidi & Li (2021) compared the use of gloves-plus-gown with no barrier to detect routes of transmission of a surrogate marker performing examinations on mannequins. Transfer by hands occurred in a smaller proportion of observations in the gloves-plus-gown group (OR, 0.06; P = .002) versus the no-barriers group. In comparison to the no-barriers group, transfer by stethoscopes was significantly lower in the gloves-plus-gown group (OR, 0.14; P = 0.005). Stethoscope transfer occurred very frequently when no barriers were worn (30% for C. difficile spores, 47% for MS2, and 66% for fluorescent marker), stethoscope transfer also occurred ≥17% of the time for C. difficile spores and MS2 and ≥33% for fluorescent marker when gloves plus gowns were worn.

Two of 30 participants (6.7%) transferred at least 1 marker to the environment in the glove-plus-gown group versus 19 of 30 subjects (63.3%) in the no-barrier group (significantly lower).

Harris (2021) compared universal gloving and gowning as an intervention bundle to standard care on the acquisition of any antibiotic-resistant gram-negative bacteria in a randomized controlled trial. Universal gloving and gowning showed a decrease in acquisition of any antibiotic-resistant gram-negative bacteria (RR=0.90; 95% CI 0.71 to 1.12; P = 0.34) and a rate difference of −2.1 (95% CI –5.9 to 1.7; P = 0.34).

Effects on each individual bacteria acquisition were: carbapenem-resistant Enterobacteriaceae (RR=0.86; 95% CI 0.60 to 1.24; P = 0.43), carbapenem resistant Acinetobacter (RR=0.81; 95% CI 0.52 to 1.27; P = 0.36), carbapenem-resistant Pseudomonas (RR=0.88; 95% CI 0.55 to 1.42; P = 0.62), and extended-spectrum β-lactamase–producing bacteria (RR=0.94; 95% CI 0.71 to 1.24; P = 0.67).

Healthcare-related infections

Comparison gloves versus no gloves

There were no studies included that described the outcome measure healthcare-related infections for the comparison gloves vs no gloves.

Chang (2019) conducted a meta-analysis including four studies to compare universal gloving as a stand-alone intervention with standard care on healthcare-associated infections. The pooled results of the 4 studies showed a significant association between universal gloving and reduced incidence of all HAI (Incidence rate ratio 0.77; 95% CI, 0.67–0.89, in favour of universal gloving). The results of the individual studies or a forest plot were not available.

Chang (2019) conducted a meta-analysis including 8 studies to compare universal gloving as a stand-alone intervention or as part of an intervention bundle with standard care on healthcare-associated infections. When the 8 included studies were pooled, there was a significant association between universal gloving and the incidence of healthcare-associated infections. (Incidence rate ratio 0.80; 95% CI 0.67 to 0.96, in favour of universal gloving). There was moderate heterogeneity between studies (I² = 59%).

Comparison gloves and gowns versus no gloves and gowns

There were no studies included that described the outcome measure healthcare-related infections for the comparison gloves and gowns vs no gloves and no gowns.

Chang (2019) conducted a meta-analysis including four studies to compare an intervention bundle (including universal gloving and gowns) with standard care on healthcare-associated infections. The pooled results of the 4 studies did not show a statistically significant effect on the incidence of healthcare-associated infections (Incidence rate ratio, 0.95; 95% CI 0.86 to 1.05, in favour of the intervention bundle). The results of the individual studies or a forest plot were not available.

Wearing comfort

There were no studies included that described the outcome measure wearing comfort.

Level of evidence of the literature

Transmission of microorganisms (transmission to healthcare worker, transmission from patient to patient, contamination of clothing with micro-organism)

The level of evidence regarding the outcome measure transmission of microorganisms started at low (observational studies) and was downgraded by 2 levels because of applicability (-1; bias due to indirectness: marker virus and/or mannequin) and number of included patients (-1: imprecision) to very low.

Healthcare-related infections

The level of evidence regarding the outcome measure transmission of microorganisms was downgraded by 3 levels because of study limitations (-1; risk of bias: no blinding) applicability (-1; bias due to indirectness); number of included patients (-1; imprecision) to very low.

Wearing comfort

There were no studies included that described the outcome measure wearing comfort.

A systematic review of the literature was performed to answer the following question:

When does wearing gloves or gowns provide added value in limiting the chance of transmitting health care related infections via and/or to health care workers?

P: Healthcare workers

I:  Gloves (non-sterile)

C: No gloves (or standard care)

O: Transmission of microorganisms (transmission to healthcare worker, transmission from patient to patient, contamination of clothing with microorganisms), healthcare-related infections, wearing comfort.

Relevant outcome measures

The guideline development group considered prevention of transmission of micro-organisms and healthcare-related infections as a critical outcome measure for decision making.

A priori, the working group did not define the outcome measures listed above but used the definitions used in the studies.

The working group defined the GRADE-standard limit of 25% difference for dichotomous outcomes (RR < 0.8 or > 1.25), and 10% for continuous outcomes as a minimal clinically (patient) important difference.

Search and select (methods)

The databases Embase, Ovid/Medline and Cinahl were searched with relevant search terms from 2014 until 18-5-2022. For this guideline, all PICOs for different types of PPE were taken together in one search. The detailed search strategy is available on request (info@sri-richtlijnen.nl). The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 671 hits. Studies were selected based on the following criteria: reporting on personal protective equipment (PPE) and its role in transmission of micro-organisms. Studies regarding the operating room were excluded since these issues are addressed in the SRI guideline “Infectiepreventie op het OK complex”. For gloves and gowns, nine studies were initially selected based on title and abstract screening. After reading the full text five studies were excluded (see the table with reasons for exclusion under the tab Methods) and four studies were included in the analysis of the literature (Alhmidi & Cadnum, 2021; Alhmidi & Li, 2021; Harris, 2021; Chang, 2019). The summary of literature, results and evidence tables are included below.

Results

Four studies were included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.