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"Equipment Contamination - prevention "
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Equivalent performance of single-use and reusable duodenoscopes in a randomised trial
2021
ObjectiveSingle-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use and reusable duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).DesignPatients with native papilla requiring ERCP were randomised to single-use or reusable duodenoscope. Primary outcome was comparing number of attempts to achieve successful cannulation of desired duct. Secondary outcomes were technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events.Results98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures. While median number of attempts to achieve successful cannulation was significantly lower for single-use cohort (2 vs 5, p=0.013), ease of passage into stomach (p=0.047), image quality (p<0.001), image stability (p<0.001) and air–water button functionality (p<0.001) were significantly worse. There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts. On multivariate logistic regression analysis, only duodenoscope type (single-use) was associated with less than six attempts to achieve selective cannulation (p=0.012), when adjusted for patient demographics, procedural complexity and type of intervention.ConclusionGiven the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands.Trial registration numberClinicaltrials.gov number: NCT04143698
Journal Article
Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial
2021
Two billion peripheral venous catheters are sold globally each year, but the optimal skin disinfection and types of devices are not well established. We aimed to show the superiority of disinfection with 2% chlorhexidine plus alcohol over 5% povidone iodine plus alcohol in preventing infectious complications, and of closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes used in combination (innovation group) over open catheters and three-way stopcocks for treatment administration (standard group) in preventing catheter failure.
We did an open-label, randomised-controlled trial with a two-by-two factorial design, for which we enrolled adults (age ≥18 years) visiting the emergency department at the Poitiers University Hospital, France, and requiring one peripheral venous catheter before admission to the medical wards. Before catheter insertion, patients were randomly assigned (1:1:1:1) using a secure web-based random-number generator to one of four treatment groups based on skin preparation and type of devices (innovative devices or standard devices; 2% chlorhexidine plus alcohol or 5% povidone iodine plus alcohol). Primary outcomes were the incidence of infectious complications (local infection, catheter colonisation, or bloodstream infections) and time between catheter insertion and catheter failure (occlusion, dislodgment, infiltration, phlebitis, or infection). This study is registered with ClinicalTrials.gov, NCT03757143.
1000 patients were recruited between Jan 7, and Sept 6, 2019, of whom 500 were assigned to the chlorhexidine plus alcohol group and 500 to the povidone iodine plus alcohol group (250 with innovative solutions and 250 with standard devices in each antiseptic group). No significant interaction was found between the two study interventions. Local infections occurred less frequently with chlorhexidine plus alcohol than with povidone iodine plus alcohol (0 [0%] of 496 patients vs six [1%] of 493 patients) and the same was observed for catheter colonisation (4/431 [1%] vs 70/415 [17%] catheters among the catheters cultured; adjusted subdistribution hazard ratio 0·08 [95% CI 0·02–0·18]). Median time between catheter insertion and catheter failure was longer in the innovation group compared with the standard group (50·4 [IQR 29·6–69·4] h vs 30·0 [16·6–52·6] h; p=0·0017). Minor skin reactions occurred in nine (2%) patients in the chlorhexidine plus alcohol group and seven (1%) patients in the povidone iodine plus alcohol group.
For skin antisepsis, chlorhexidine plus alcohol provides greater protection of peripheral venous catheter-related infectious complications than does povidone iodine plus alcohol. Use of innovative devices extends the catheter complication-free dwell time.
Becton Dickinson.
Journal Article
A New Drying Method of Thermolabile Flexible Endoscope Channels by Laminar and Turbulent Airflow: A Prospective, Randomized-Controlled, Single-Center, Proof-of-Concept Trial
by
Friedrich-Rust, Mireen
,
Walter, Dirk
,
Puhlmann, Danuta
in
Air flow
,
Bacteria
,
Disease control
2025
INTRODUCTION:International guidelines suggest different possibilities for drying of endoscopes during reprocessing. Clinical results of these available drying methods are not satisfactory. The aim of this study was to compare the drying cycle of a standard endoscope washer-disinfector (EWD) (standard drying method [SD]) with a shortened mandatory drying by the EWD followed by a special drying device using laminar and turbulent air flow (novel drying method [ND]).METHODS:Sixty endoscopes (duodenoscopes, colonoscocopes, and gastroscopes) from 3 different manufacturers underwent high-level disinfection and drying depending on the randomization group. Operational time of drying was measured for both groups. Residual fluid in the channels was measured using a laboratory scale. After a 14-day storage period, a sample of the endoscope channels was obtained to determine bacterial contamination.RESULTS:ND had significantly fewer residual water in endoscope channels (SD: 90% vs ND: 0%; P < 0.001) after high-level disinfection and drying and less bacterial contamination after storage for 14 days (SD: 47% vs ND: 20%; P = 0.028). Time consumed for drying in ND was also significantly shorter (SD: 16 minutes 4 seconds vs ND: 5 minutes 59 seconds; P < 0.001).DISCUSSION:Drying with a special automatic drying device was superior compared with an EWD's drying program as evidenced by no measurable residual water, reduced microbiological contamination, and a more than 2-fold decrease in operational time. Thus, drying by laminar and turbulent airflow may represent an attractive alternative to the currently used standard approach in the reprocessing process of flexible endoscopes.
Journal Article
Contamination and washing of cloth masks and risk of infection among hospital health workers in Vietnam: a post hoc analysis of a randomised controlled trial
by
Dung, Tham Chi
,
Seale, Holly
,
Rahman, Bayzidur
in
Adult
,
Betacoronavirus
,
Coronavirus Infections - epidemiology
2020
BackgroundIn a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. This was the only published RCT of cloth masks at the time of the COVID-19 pandemic.ObjectiveTo do a post hoc analysis of unpublished data on mask washing and mask contamination from the original RCT to further understand poor performance of the two-layered cotton cloth mask used by HCWs in that RCT.Setting14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.ParticipantsA subgroup of 607 HCWs aged ≥18 years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks.InterventionWashing method for cloth masks (self-washing or hospital laundry). A substudy of contamination of a sample of 15 cloth and medical masks was also conducted.Outcome measureInfection rate over 4 weeks of follow up and viral contamination of masks tested by multiplex PCR.ResultsViral contamination with rhinovirus was identified on both used medical and cloth masks. Most HCW (77% of daily washing) self-washed their masks by hand. The risk of infection was more than double among HCW self-washing their masks compared with the hospital laundry (HR 2.04 (95% CI 1.03 to 4.00); p=0.04). There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).ConclusionsUsing self-reported method of washing, we showed double the risk of infection with seasonal respiratory viruses if masks were self-washed by hand by HCWs. The majority of HCWs in the study reported hand-washing their mask themselves. This could explain the poor performance of two layered cloth masks, if the self-washing was inadequate. Cloth masks washed in the hospital laundry were as protective as medical masks. Both cloth and medical masks were contaminated, but only cloth masks were reused in the study, reiterating the importance of daily washing of reusable cloth masks using proper method. A well-washed cloth mask can be as protective as a medical mask.Trial resgistration numberACTRN12610000887077.
Journal Article
Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial
by
Buret, Andre G.
,
Mohamed, Rachid
,
Turbide, Christian
in
Automation
,
Bioluminescence
,
Cholangiopancreatography, Endoscopic Retrograde - instrumentation
2020
Background
Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized endoscopes used to perform ERCP, and inherent to their design, a high rate of persistent bacterial contamination exists even after automated reprocessing and disinfection. Consequently, in recent years, ERCP has been associated with infection transmission, leading to several fatal patient outbreaks. Due to increasing fears over widespread future duodenoscope-related outbreaks, regulatory bodies have called for alterations in the design of duodenoscopes. A duodenoscope has recently been developed that employs a disposable cap. This novel design theoretically eliminates the mechanism behind persistent bacterial contamination and infection transmission. However, there are no data demonstrating persistent bacterial contamination rates, technical success rates, or clinical outcomes associated with these duodenoscopes.
Methods
A parallel arm randomized controlled trial will be performed for which 520 patients will be recruited. The study population will consist of consecutive patients undergoing ERCP procedures for any indication at a high-volume tertiary care centre in Calgary, Alberta, Canada. Patients will be randomized to an intervention group, that will undergo ERCP with a novel duodenoscope with disposable cap, or to a control group who will undergo ERCP with a traditional duodenoscope. Co-primary outcomes will include persistent bacterial contamination rates (post automated reprocessing) and ERCP technical success rates. Secondary outcomes include clinical success rates, overall and specific early and late adverse event rates, 30-day mortality and healthcare utilization rates, procedure and reprocessing times, and ease of device use.
Discussion
The ICECAP trial will answer important questions regarding the use of a novel duodenoscope with disposable cap. Specifically, persistent bacterial contamination, technical performance, and relevant clinical outcomes will be assessed. Given the mortality and morbidity burden associated with ERCP-related infectious outbreaks, the results of this study have the capacity to be impactful at an international level.
Trial registration
This trial was registered on clinicaltrials.gov (
NCT04040504
) on July 31, 2019.
Journal Article
A Novel Flocked Swab Protocol Proves to Be an Effective Method for Culturing Elevator-Containing Endoscopes
2022
BackgroundThe challenging disinfection process for the elevator mechanism on duodenoscopes and linear echoendoscopes has been identified as a source of clinically significant bacterial transmission. Despite increased awareness, there continues to be a lack of definitive guidelines for bacterial culturing protocols for elevator-containing endoscopes.AimsTo compare two different prospective bacterial surveillance protocols for duodenoscopes and linear echoendoscopes with regard to accuracy, efficiency, and cost.MethodsConsecutive duodenoscopes and linear echoendoscopes used at a single tertiary care center were reprocessed following hospital and manufacturer guidelines, dried using an automatic endoscope-drying machine, and hung overnight in an upright position. Following reprocessing, culture samples were sequentially obtained from each endoscope using two methods, first, the brush protocol followed immediately by the swab protocol.ResultsA total of 532 primary cultures were collected from 17 duodenoscopes and eight linear echoendoscopes. Of these, 266 cultures gathered using the brush protocol were negative, while 266 cultures gathered using the swab protocol resulted in three positive cultures (1.1%). Positive cultures showed Enterobacter cloacae and Klebsiella pneumoniae from one duodenoscope and two linear echoendoscopes. Yearly, the brush protocol amounts to approximately 520 nursing hours, and the swab protocol takes an estimated 42 nursing hours. Annually, the swab protocol could save over $26,500 and 478 nursing hours.ConclusionsThe proposed swab protocol was superior to the brush protocol when evaluating the presence of residual bacteria on elevator-containing endoscopes following reprocessing and saves cost and nursing hours.
Journal Article
Bacterial Colonization of Silver‐Additive Ventilator Circuit in Patients Receiving Mechanical Ventilation: A Randomized Controlled Trial
by
Chao, Ke‐Yun
,
Yang, Shih‐Hsing
,
Liu, Wei‐Lun
in
Aged
,
antimicrobial agent
,
Bacteria - isolation & purification
2025
Introduction Mechanical ventilation is a significant risk factor for developing ventilator‐associated pneumonia. Although silver‐coated endotracheal tubes have been shown to reduce the bacterial burden, the efficacy of silver‐based ion additive ventilator circuits in reducing bacterial colonization remains unclear. Methods This single‐site, randomized controlled trial compared the incidence of bacterial contamination between a silver‐additive ventilator circuit and a ventilator circuit that did not have a silver additive. Bacterial samples were collected from the inspiratory limb and Y‐adaptor of the circuit and analyzed using culture and identification methods. Results Bacterial growth was observed in all samples from the control group and in 93.7% and 81.2% of inspiratory limb and Y‐adaptor samples, respectively, from the study group. The colony counts in the inspiratory limb samples were significantly different between the groups, with a higher proportion of undesirable colony counts in the control group compared with the study group. No significant difference between the groups was observed in the colony counts in the Y‐adaptor samples. Conclusion The use of a silver‐additive ventilator circuit may reduce bacterial circuit colonization. However, further research with larger sample sizes and more diverse patient populations is necessary to confirm these findings. Trial Registration: ClinicalTrial.gov: NCT04927806 Configuration of ventilator system and sampling site. (A) Inlet tube of heated humidifier. (B) Inspiratory limb. (C) Y‐adaptor. HEPA: high‐efficiency particulate air.
Journal Article
A multicenter study comparing the bacterial reduction on flexible endoscopes without a working channel between UV-C light disinfection versus standard endoscope Washer Disinfection: a randomized controlled trial
by
van Bemmel, A. J. M.
,
Sikkema, H.
,
van den Berge, H.
in
Adult
,
Bacteria - classification
,
Bacteria - radiation effects
2024
Background
To prevent cross-contamination between patients, adequate reprocessing is necessary when using flexible endoscopes (FEs) without a working channel. The current reprocessing process using an Endoscope Washer Disinfector (EWD) is time-consuming. Ultraviolet light group C (UV-C) exposition is an alternative and fast disinfection method and has previously been shown to adequately reduce Colony Forming Units (CFUs) on FEs without a working channel. The objective of this study was to examine whether UV-C light is as effective in reducing CFUs on contaminated FEs without a working channel compared to the EWD.
Methods
FEs without a working channel were collected in three different Otorhinolaryngology Departments in the Netherlands. After pharyngolaryngoscopy, a manual pre-cleaning with tap water was performed and a culture was collected by rolling the distal 8–10 cm of the FE over an agar plate. Next, the FE was randomly assigned to be disinfected with UV-C light (D60) or the EWD (gold standard). After disinfection, another culture was taken. The primary outcome was microbiological contamination, defined by Colony Forming Units (CFU).
Results
600 FEs without a working channel were randomized. After clinical use and manual pre-cleaning, 239/300 (79.7%) FEs in the UV-C group and 262/300 (87.3%) FEs in the EWD group were contaminated (i.e., > 0 CFU). FEs without culture confirmed contamination were excluded from further analysis. After UV-C light disinfection, 195/239 (81.6%) FEs showed 0 CFUs, compared to 187/262 (71.4%) FEs disinfected with the EWD (
p
< 0.01). A multivariate logistics regression analysis showed an increased odds of 0 CFUs when using UV-C light (OR 1.83, 95% CI 1.19–2.79;
p
< 0.01), conditional on participating hospitals and types of FE.
Conclusions
UV-C light disinfection of FEs without a working channel appears more effective in reducing CFUs compared to the EWD and might be a good alternative disinfection method.
Trial registration
Not applicable.
Journal Article
A clinical trial of silver-coated and tapered cuff plus supraglottic suctioning endotracheal tubes in preventing ventilator-associated pneumonia
2020
Novel designs of the endotracheal tube (ETT) are emerged to reduce the risk of ventilator-associated pneumonia (VAP). We evaluated the effect of two different types, namely silver-coated (Bactiguard) and subglottic suctioning (Taperguard) ETTs, on the incidence of VAP in critically-ill patients.
A total of 90 patients, mechanically ventilated for >72 h, were randomly assigned to Bactiguard and Taperguard groups. They otherwise received routine care, including VAP prevention measures during their intensive care unit (ICU) stay. Subglottic suctioning was performed in Taperguard group. Statistical analyses were performed using SPSS 25 for iMacs.
Both groups had similar demographics and did not differ in the prevalence of comorbidities and the severity of underlying illness. There was no difference in the frequency of reintubation (P = .565), the duration of ventilation, ICU and total hospital length of stay. VAP developed in 31% of the Bactiguard group and 20% of the Taperguard group (P = .227). Nearly twice the number of patients died in the Bactiguard group compared to the Taperguard group. This difference was not significant either (P = .352).
The use of Bactiguard or Taperguard ETTs was not associated with any difference in the incidence of VAP or ICU mortality.
•Several prototypes of the endotracheal tubes are used to decrease the risk of VAP.•Subglottic suctioning (TaperGuard) tubes have been credited to decrease the prevalence of VAP.•Silver-coated tubes (BactiGurad) are manufactured to reduce the risk of bacterial VAP.•BactiGuard tubes were comparable to TaperGuard tubes for the risk of VAP.
Journal Article
Antimicrobial surface coating in the emergency department as protective technology for infection control (ASEPTIC): a pilot randomized controlled trial
by
Pua, Yong Hao
,
Boon, Yuru
,
Ng, Abigail
in
Anti-Infective Agents - pharmacology
,
Antimicrobial coating
,
Bacteria
2024
Study objective
We examined the effectiveness of an antimicrobial surface coating for continual disinfection of high touch-frequency surfaces in the emergency department (ED).
Methods
Following a preliminary observation identifying stretcher rails as the surface with highest touch-frequency in the ED, we conducted a pilot randomized controlled trial involving 96 stretcher rails. The stretchers were randomized to receive an antimicrobial surface coating or placebo coating. Routine cleaning of stretchers subsequently continued as per hospital protocol in both arms. Sampling for total aerobic, gram-positive halophilic, gram-negative and methicillin-resistant
Staphylococcus aureus
bacteria was performed pre- and post-treatment at 24 h, 7 days and 180 days. Individuals who applied the coating and outcome assessors were blinded to the allocated arms. The primary outcome is contamination of antimicrobial versus placebo rails measured as colony forming units per cm
2
(CFU/cm
2
).
Results
Baseline total aerobic bacteria was comparable between placebo and intervention arms (0.84 versus 1.32 CFU/cm
2
,
P
= 0.235). Total aerobic bacteria contamination was significantly lower on antimicrobial versus placebo rails at 24 h (0.61 versus 1.01 CFU/cm
2
, median difference 0.40 CFU/cm
2
, 95% confidence interval [CI] 0.01 to 1.01 CFU/cm
2
). There was a non-statistically significant tendency for contamination to be lower on antimicrobial versus placebo rails at 7 days (1.15 versus 1.50 CFU/cm
2
, median difference 0.35 CFU/cm
2
, 95% CI -0.64 to 1.28 CFU/cm
2
), but higher at 180 days (2.06 versus 1.84 CFU/cm
2
, median difference − 0.22 CFU/cm
2
, 95% CI -1.19 to 0.78 CFU/cm
2
).
Conclusion
This is the first double-blinded, placebo-controlled, randomized trial to evaluate an antimicrobial surface coating on high touch-frequency surfaces in the emergency department. Total aerobic bacteria found on antimicrobial-coated patient transport stretcher rails was significantly lower than placebo rails at 24 h.
Journal Article