ddPCR enables rapid detection of bloodstream infections in patients on home parenteral nutrition: A prospective cohort study.

INTRODUCTION: Chronic intestinal failure patients (CIF) require a central venous access device (CVAD) to administer parenteral nutrition. Most serious complication related to a CVAD is a central line-associated bloodstream infection (CLABSI). The golden standard to diagnose a CLABSI are blood cultures, however, they may require 1-5 days before getting a result. Droplet digital polymerase chain reaction (ddPCR) for the detection of pathogen 16S/28S rRNA is a novel culture-independent molecular technique that has been developed to enhance and expedite infection diagnostics within two and a half hours. In this study, we prospectively compared ddPCR with blood cultures to detect pathogens in whole blood. METHODS: We included adult CIF patients with a clinical suspicion of CLABSI in this prospective single-blinded clinical study. Blood cultures were routinely collected and subsequently two central samples from the CVAD and two peripheral samples from a peripheral venous access point. Primary outcome was the sensitivity and specificity of ddPCR. RESULTS: In total, 75 patients with 126 suspected CLABSI episodes were included, with 80 blood samples from the CVAD and 114 from peripheral veins. The central ddPCR samples showed a sensitivity of 91% (95%CI 77-98), and specificity of 96% (95%CI 85-99). Peripheral ddPCR samples had a sensitivity of 63% (95%CI 46-77) and specificity of 99% (95%CI 93-100). CONCLUSION: ddPCR showed a high sensitivity and specificity relative to blood cultures and enables rapid pathogen detection and characterization. Clinical studies should explore if integrated ddPCR and blood culture outcomes enables a more rapid pathogen guided CLABSI treatment and enhancing patient outcomes.

Association of disparities in known minor histocompatibility antigens with relapse-free survival and graft-versus-host disease after allogeneic stem cell transplantation.

Allogeneic stem cell transplantation (allo-SCT) can induce remission in patients with hematologic malignancies due to graft-versus-tumor (GVT) responses. This immune-mediated antitumor effect is often accompanied by detrimental graft-versus-host disease (GVHD), however. Both GVT and GVHD are mediated by minor histocompatibility antigen (MiHA)-specific T cells recognizing peptide products from polymorphic genes that differ between recipient and donor. In this study, we evaluated whether mismatches in a panel of 17 MiHAs are associated with clinical outcome after partially T cell-depleted allo-SCT. Comprehensive statistical analysis revealed that DNA mismatches for one or more autosomal-encoded MiHAs was associated with increased relapse-free survival in recipients of sibling transplants (P = .04), particularly in those with multiple myeloma (P = .02). Moreover, mismatches for the ubiquitous Y chromosome-derived MiHAs resulted in a higher incidence of acute GVHD grade III-IV (P = .004), whereas autosomal MiHA mismatches, ubiquitous or restricted to hematopoietic cells, were not associated with severe GVHD. Finally, we found considerable differences among MiHAs in their capability of inducing in vivo T cell responses using dual-color tetramer analysis of peripheral blood samples collected after allo-SCT. Importantly, detection of MiHA-specific T cell responses was associated with improved relapse-free survival in recipients of sibling transplants (P = .01). Our findings provide a rationale for further boosting GVT immunity toward autosomal MiHAs with a hematopoietic restriction to improve outcomes after HLA-matched allo-SCT.

Antiseptic barrier caps to prevent central line-associated bloodstream infections: A systematic review and meta-analysis.

BACKGROUND: Reliable and safe venous access is crucial for patients using central venous catheters (CVC). However, such CVCs carry a risk for central line-associated bloodstream infections (CLABSIs). Antiseptic barrier caps (ABCs) are a novel tool in the armamentarium for CVC disinfection. Our aim was to review the efficacy and safety of ABCs. METHOD: A literature search was conducted using MedLine, EMBASE, Cochrane library, and CINAHL. Primary aim was to compare CLABSI rates in patients using ABCs versus standard care. Secondary aims included efficacy of ABCs in relevant subgroups (age, ABC brand, clinical setting), safety, compliance, and costs. Fifteen studies were included in the meta-analysis. RESULTS: In total, 391 CLABSIs in 273,993 catheter days occurred in the intervention group versus 620 CLABSIs in 284,912 days in the standard care group, resulting in a risk ratio of 0.65 (95%CI 0.55-0.76; P < .00001). Subgroup analyses showed similar effects, except for nonintensive care unit. In general, ABCs were safe, highly appreciated by patients and caregivers, and cost-effective, while compliance was easy to monitor. In most studies, a substantial risk of bias was observed. CONCLUSION: In conclusion, while available evidence suggests that ABCs are effective, safe, easy in use, and cost-effective. However, due to the poor methodological quality of most available studies, more robust data should justify their use at this point.

Randomized clinical trial: Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition.

BACKGROUND & AIMS: Staphylococcus aureus decolonization has proven successful in prevention of S. aureus infections and is a key strategy to maintain venous access and avoid hospitalization in patients receiving home parenteral nutrition (HPN). We aimed to determine the most effective and safe long-term S. aureus decolonization regimen. METHODS: A randomized, open-label, multicenter clinical trial was conducted. Adult intestinal failure patients with HPN support and carrying S. aureus were randomly assigned to a 'continuous suppression' (CS) strategy, a repeated chronic topical antibiotic treatment or a 'search and destroy' (SD) strategy, a short and systemic antibiotic treatment. Primary outcome was the proportion of patients in whom S. aureus was totally eradicated during a 1-year period. Secondary outcomes included risk factors for decolonization failure and S. aureus infections, antimicrobial resistance, adverse events, patient compliance and cost-effectivity. RESULTS: 63 participants were included (CS 31; SD 32). The mean 1-year S. aureus decolonization rate was 61% (95% CI 44, 75) for the CS group and 39% (95% CI 25, 56) for the SD group with an OR of 2.38 (95% CI 0.92, 6.11, P = 0.07). More adverse effects occurred in the SD group (P = 0.01). Predictors for eradication failure were a S. aureus positive caregiver and presence of a (gastro)enterostomy. CONCLUSION: We did not demonstrate an increased efficacy of a short and systemic S. aureus decolonization strategy over a continuous topical suppression treatment. The latter may be the best option for HPN patients as it achieved a higher long-term decolonization rate and was well-tolerated (NCT03173053).

Anticoagulants decrease the risk for catheter-related venous thrombosis in patients with chronic intestinal failure: A long-term cohort study.

BACKGROUND: Catheter-related venous thrombosis (CRVT) is a severe complication of home parental nutrition. Although primary prevention of CRVT is crucial, there is no consensus on anticoagulant use to prevent this adversity. The aim was to compare CRVT risk in patients with chronic intestinal failure (CIF) in the presence or absence of anticoagulants, and to identify CRVT risk factors. METHODS: This retrospective cohort study comprised adult patients with CIF with a central venous access device (CVAD) between 2010 and 2020 that were treated at our national CIF referral center. Analyses were performed at a CVAD level. RESULTS: Overall, 1188 CVADs in 389 patients were included (540.800 CVAD days). Anticoagulants were used in 403 CVADs. In total, 137 CRVTs occurred in 98 patients, resulting in 0.25 CRVTs/1000 CVAD days (95% CI, 0.22-0.29). Anticoagulant use was associated with a decreased CRVT risk (odds ratio [OR] = 0.53; 95% CI, 0.31-0.89; P = 0.02). Left-sided CVAD insertion (OR = 2.00; 95% CI, 1.36-2.94), a history of venous thrombosis (OR = 1.73; 95% CI, 1.05-2.84), and a shorter period postinsertion (OR = 0.78; 95% CI, 0.65-0.92) were independently associated with an increased CRVT risk. CONCLUSION: Anticoagulants decreased the CRVT risk. In addition, we identified left-sided vein insertion, a history of venous thrombosis, and a shorter period post-CVAD insertion as CRVT risk factors. Further prospective studies should provide guidance whether prophylactic anticoagulant use, especially in higher-risk patients with a left-sided CVAD or a history of venous thrombosis, is justified.

The Antiseptic and Antineoplastic Agent Taurolidine Modulates Key Leukocyte Functions.

BACKGROUND/AIM: Although taurolidine is known to exert a wide spectrum of biological actions, its effects on immune cells have not been characterized in detail. In this study, we investigated the ex vivo effects of taurolidine on relevant innate and adaptive immune cell functions. MATERIALS AND METHODS: Leukocyte functions in whole blood were assessed following treatment with various taurolidine concentrations. Viability of peripheral blood mononuclear cells (PBMCs) and granulocytes was measured using the WST-1 assay. PBMC function was assessed by measuring TNFα and IFNγ production after stimulation with lipopolysaccharide (LPS) or Candida, respectively. Reactive oxygen species (ROS) production by granulocytes was measured in whole blood using luminol-enhanced chemiluminescence. Granulocyte degranulation and activation were evaluated by membrane expression of degranulation (CD63, CD66B) and adhesion markers (CD62L, CD11b) using immunofluorescent staining followed by flow-cytometric analysis. RESULTS: Taurolidine decreased viability of PBMCs and granulocytes: after 2 h, IC50 concentrations were 500 and 520 µg/ml, respectively. Following prolonged exposure (≥24 h) of PBMCs, the IC50 concentrations declined to 40 µg/ml. PBMC cytokine production significantly decreased at taurolidine concentrations below the cytotoxic threshold, whereas no changes in ROS production were observed. The expression of all granulocyte adhesion and degranulation markers increased at concentrations higher than 500 µg/ml (the cytotoxic level of taurolidine). CONCLUSION: Taurolidine exhibits a dose- and time-dependent cytotoxicity toward PBMCs and granulocytes. The effects on PBMCs, as exemplified by a decrease in cytokine production, occurred below the toxic threshold, whereas granulocyte function (ROS production) remained unchanged at these taurolidine concentrations. Granulocyte activation and degranulation markers only increased at cytotoxic taurolidine concentrations.

Use of Catheter Lock Solutions in Patients Receiving Home Parenteral Nutrition: A Systematic Review and Individual-Patient Data Meta-Analysis.

BACKGROUND: Use of catheter lock solutions (CLSs) as a strategy to prevent catheter-related bloodstream infections (CRBSIs) has been evaluated in recent clinical trials. Our aim was to identify the most effective CLS formulation in patients receiving home parenteral nutrition (HPN). METHODS: We conducted a systematic review and individual-patient data meta-analysis (IPDMA). Prospective randomized clinical trials in adult HPN patients using CLS were identified from PubMed, EMBASE, Web of Science, CINAHL, Cochrane library, and ClinicalTrials.gov. Primary outcome was the number of CRBSIs per 1000 catheter days for each CLS. Other outcomes included time to CRBSI and identification of patients with a higher risk for CRBSIs. RESULTS: In total, 1107 studies were screened for eligibility, of which three studies comprising 162 HPN patients and 45,695 catheter days were included in the IPDMA. CRBSI rates were significantly decreased in patients using taurolidine (rate 0.13; 95% confidence interval [CI], 0.05-0.32) when compared with saline (rate 0.74; 95% CI, 0.31-1.74; P = .002) or heparin (rate 2.01; 95% CI, 1.03-3.91; P < .001). The cumulative proportion of CRBSI-free patients using taurolidine, saline, and heparin after 1 year was 88%, 56%, and 14%, respectively. Three risk factors for CRBSIs were identified: type of CLS, intestinal dysmotility as underlying condition, and use of central venous catheters. CONCLUSIONS: Taurolidine was the most effective CLS formulation in HPN patients for the prevention of CRBSIs. We suggest discussing with patients the benefits and risks when starting taurolidine, especially in patients who are considered to have a higher risk for CRBSIs.

Contribution of Genetic and Clinical Risk Factors to Development of Candidemia in Patients Receiving Home Parenteral Nutrition.

BACKGROUND: Patients receiving home parenteral nutrition (HPN) have an increased risk for central line-associated bloodstream infections (CLABSIs), including candidemia. Recently, 7 single-nucleotide polymorphisms (SNPs) in TLR1, CD58, LCE4A-Clorf68, and TAGAP have been associated with the development of candidemia. Identification of host-genetic as well as clinical risk factors may help to identify patients who have an increased susceptibility to such infections. The aim of this study was to investigate the relevance of the reported SNPs in patients receiving HPN, and to explore clinical risk factors associated with candidemia. METHODS: We analyzed blood samples of adult patients who started HPN between 1976 and 2017 at our referral center for intestinal failure. Primary outcome was the association between TLR1, CD58, LCE4A-Clorf68, or TAGAP SNPs and candidemia. Secondary outcomes included the relation between severity of infection and these SNPs, and clinical risk factors for candidemia. RESULTS: Of 341 included patients, 42 (12%) experienced a candidemia (range 1-6). None of the 7 SNPs were associated with candidemia or the severity of infection. The rate of non-Candida-related CLABSIs was significantly associated with candidemia (rate ratio, 1.29; 95% CI, 1.14-1.46; P < 0.001). CONCLUSIONS: None of 7 known SNPs in TLR1, CD58, LCE4A-Clorf68, or TAGAP were associated with candidemia or severity of infection in patients receiving HPN. The rate of non-Candida-related CLABSIs was significantly associated with the development of candidemia. The latter supports the key role of aseptic catheter handling with respect to Candida susceptibility in patients receiving HPN.

Droplet digital polymerase chain reaction for rapid broad-spectrum detection of bloodstream infections.

The droplet digital polymerase chain reaction (ddPCR) is a novel molecular technique that allows rapid quantification of rare target DNA sequences. Aim of this study was to explore the feasibility of the ddPCR technique to detect pathogen DNA in whole blood and to assess the diagnostic accuracy of ddPCR to detect bloodstream infections (BSIs), benchmarked against blood cultures. Broad-range primers and probes were designed to detect bacterial 16S rRNA (and Gram stain for differentiation) and fungal 28S rRNA. To determine the detection limit of ddPCR, 10-fold serial dilutions of E. coli and C. albicans were spiked in both PBS and whole blood. The diagnostic accuracy of ddPCR was tested in historically collected frozen blood samples from adult patients suspected of a BSI and compared with blood cultures. Analyses were independently performed by two research analysts. Outcomes included sensitivity and specificity of ddPCR. Within 4 h, blood samples were drawn, and DNA was isolated and analysed. The ddPCR detection limit was approximately 1-2 bacteria or fungi per ddPCR reaction. In total, 45 blood samples were collected from patients, of which 15 (33%) presented with positive blood cultures. The overall sensitivity of ddPCR was 80% (95% CI 52-96) and specificity 87% (95% CI 69-96). In conclusion, the ddPCR technique has considerable potential and is able to detect very low amounts of pathogen DNA in whole blood within 4 h. Currently, ddPCR has a reasonable sensitivity and specificity, but requires further optimization to make it more useful for clinical practice.

Repair of damaged central venous catheters is safe and doubles catheter survival: a home parenteral nutrition patient cohort study.

BACKGROUND & AIMS: Repeated central venous catheter loss due to complications, including material breakage, compromises the options to obtain adequate vascular access in home parenteral nutrition (HPN) patients. It remains unclear whether repair of damaged catheters is an effective strategy to extend catheter survival, avoid surgical replacement and maintain venous access. The aim of this study was to evaluate the effectiveness and safety of catheter repair in our cohort of intestinal failure patients. METHODS: We conducted a retrospective analysis of all catheter repairs that were performed between 2006 and 2017 at our tertiary referral centre for intestinal failure. Primary outcome was the additional median catheter survival after catheter repair, as calculated with Kaplan-Meier analyses. Secondary outcomes included risk for central line-associated bloodstream infections (CLABSIs) and risk factors for catheter damage, as calculated with Poisson regression analyses. CLABSI rates in post-repair periods were compared with pre-repair periods. Pre- and post-repair periods were either short-term (30 days), or long-term (whole catheter period). RESULTS: A total of 58 repairs in 41 catheters of 35 HPN patients were included in the analysis. The median time to first repair was 452 days (interquartile range (IQR) 206-1134). After first repair, catheter survival additionally increased by 510 days (IQR 147-1195). Repairs did not increase the short-term risk for CLABSIs: incidence rates were 1.23 and 1.26 CLABSIs/1000 catheter days for the 30 days pre- and post-repair periods, respectively (rate ratio, 1.05; 95%CI, 0.15-7.44; P = 0.96). For the whole pre- and post-repair catheter period, incidence rates were 0.12 and 0.59 CLABSIs/1000 catheter days, respectively (rate ratio, 3.55; 95%CI, 1.10-11.45; P = 0.03). The overall CLABSI incidence rates in undamaged versus repaired catheters were 0.84 and 0.31 CLABSIs/1000 catheter days, respectively (rate ratio, 0.47; 95%CI, 0.23-0.94; P = 0.03). A lower age at catheter start and femoral catheterization were associated with a higher risk for catheter damage. CONCLUSIONS: Repair of damaged catheters is often successful and an effective strategy to prolong and maintain venous access in HPN patients. On the short-term, no increase in CLABSI incidence was observed. Despite a possible increase in CLABSI incidence on the long-term, overall CLABSI rates of repaired catheters remained well below the overall CLABSI incidence of undamaged catheters. The identification of two risk factors for catheter damage may help to prevent future catheter damage.

Clinical outcomes of home parenteral nutrition patients using taurolidine as catheter lock: A long-term cohort study.

BACKGROUND & AIMS: Central venous access device (CVAD)-related complications, such as central-line associated bloodstream infections (CLABSIs), CVAD-related venous thromboses (CRVTs) and -occlusions frequently occur in home parenteral nutrition (HPN) patients. A preventive strategy to decrease the incidence of CLABSIs is the use of CVAD lock solutions, such as 2% taurolidine. The aim of this study was to evaluate long-term clinical outcomes of our HPN cohort while using taurolidine as lock solution. In addition, we explored risk factors associated with CVAD-related complications. METHODS: We conducted a retrospective analysis of complications (CLABSIs, CRVTs and CVAD occlusions) and adverse events in adult HPN patients while using taurolidine as lock solution. Patients with a benign underlying disease leading to intestinal failure were included between 2006 and 2017 at our tertiary referral centre for intestinal failure. Primary outcome was the effectiveness of taurolidine, as described by complication incidence rates. Secondary objectives were to assess adverse events of taurolidine, complication rates of patients who subsequently discontinued taurolidine and started using 0.9% saline alternatively, and risk factors associated with complications. RESULTS: In total, 270 HPN patients used taurolidine during 338521 catheter days. CLABSIs, CRVTs and CVAD occlusions occurred at a rate of 0.60 (CI95% 0.52-0.69), 0.28 (CI95% 0.23-0.34), and 0.12 (CI95% 0.08-0.16) events per 1000 catheter days, respectively. In 24 (9%) patients, mild to moderate adverse events resulted in discontinuation of 2% taurolidine. A subsequent switch to 0.9% saline resulted in an increased CLABSI rate (adjusted rate ratio 4.01 (95%CI 1.23-13.04), P = 0.02). Several risk factors were identified for CLABSIs (a lower age, nontunneled catheters, infusion frequency), CRVTs (site of vein insertion), and CVAD occlusions (type of CVAD). CONCLUSION: Complication rates remained low in the long-term, and use of taurolidine was generally safe. The identified risk factors may help to create new strategies to further prevent CVAD-related complications and improve HPN care in the future.

Comparison of the Idylla™ Respiratory (IFV-RSV) panel with the GeneXpert Xpert® Flu/RSV assay: a retrospective study with nasopharyngeal and midturbinate samples.

The objective of this study was to compare the performance of the Idylla™ Respiratory (IFV-RSV) panel to the GeneXpert Xpert® Flu/RSV assay and establish the performance of a midturbinate swab compared to nasopharyngeal sampling. Considering GeneXpert® assay as imperfect reference standard, a positive percentage agreement between both assays of 98-100% for influenza A and 96-99% for influenza B could be calculated when 354 nasopharyngeal and 325 midturbinate swabs were retrospectively analyzed. Comparing midturbinate samples to nasopharyngeal specimens of 321 subjects, positive percentage agreement varied from 42% to 94% depending on both target virus and assay used. Negative percentage agreements ranged from 98% to 100% for both methods and sample type comparison. The Idylla™ assay showed excellent performance compared to the GeneXpert® assay for the detection of influenza virus. The study also showed a slightly better performance for nasopharyngeal sampling compared to the use of a midturbinate swab.

Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition: study protocol for a randomized multicenter trial.

BACKGROUND: Patients with long-term intestinal failure are usually treated by means of home parenteral nutrition (HPN) where they administer their nutritional formulation intravenously via a central venous access device (mostly a catheter). This implies that such patients are exposed to a lifelong risk of developing Staphylococcus aureus bacteremia (SAB). SAB poses a threat to both catheter and patient survival and may lead to frequent hospitalization and a permanent loss of vascular access. In other clinical settings, S. aureus carriage eradication has been proven effective in the prevention of S. aureus infections. Unfortunately, there is a complete lack of evidence in HPN support on the most effective and safe S. aureus decolonization strategy in S. aureus carriers. We hypothesized that long-term S. aureus decolonization in HPN patients can only be effective if it is aimed at the whole body (nasal and extra-nasal) and is given chronically or repeatedly on indication. Besides this, we believe that S. aureus carriage among caregivers, who are in close contact with the patient, are of great importance in the S. aureus transmission routes. METHODS/DESIGN: The CARRIER trial is a randomized, open-label, multicenter clinical trial in Dutch and Danish hospitals that treat patients on HPN. A total of 138 adult HPN patients carrying S. aureus will be randomly assigned to a search and destroy (SD) strategy, a quick and short, systemic antibiotic treatment, or a continuous suppression (CS) strategy, a repeated chronic topical antibiotic treatment. The primary outcome measure is the proportion of patients in whom S. aureus is totally eradicated during a 1-year period. Secondary outcomes are time to successful eradication, long-term antimicrobial resistance, adverse events, patient compliance, incidence of (S. aureus) infections, catheter removals, mortality rates, S. aureus transmission routes, quality of life, and health care costs. DISCUSSION: The CARRIER trial is designed to identify the most safe and effective long-term S. aureus carriage decolonization strategy in HPN patients. This will eventually lead to a better understanding of long-term S. aureus decolonization treatments in general. The results of this study will have a great impact on our daily clinical practice, which eventually may result in less S. aureus-related infections. TRIAL REGISTRATION: ClinicalTrials.gov; NCT03173053 . Registered on 1 June 2017.

Optimisation of HPMC ophthalmic inserts with sustained release properties as a carrier for thermolabile therapeutics.

A methodology was developed and optimised for the preparation of a new drug delivery system (DDS) with sustained release properties to allow ocular protein delivery and to limit destructive production steps during manufacturing. Elevated temperatures, shear forces and an oxidative environment should be avoided in order to prevent denaturation or oxidation of proteins. An aqueous HPMC solution was prepared using heat and casted into small semi-rod-shaped PVC blisters. The polymer solution was allowed to cool down and was partially dehydrated at room temperature. A drug solution containing glycerol, drug and water was subsequently added to rehydrate the partially dehydrated polymer matrix at a temperature of 2°C. Several parameters of the production process were varied to determine their influence on the release kinetics from HPMC inserts from three different molecules of different molecular weight. This production method was further optimised in order to shorten the rehydration time from weeks to days, while eliminating heat and shear forces on the selected drug molecules sodium fluorescein, lysozyme and albumin. Slow release kinetics were achieved for sodium fluorescein and lysozyme as model drug molecules. The higher molecular weight of albumin prevented a good penetration into the insert during the rehydration process resulting in predominantly burst release. The biocompatibility of a viscous HPMC solution was evaluated on SV40-human corneal epithelial cells with PrestoBlue® and no cytotoxic effects were observed.

Clinical use of a neck brace to improve hands-free speech in laryngectomized patients.

OBJECTIVES/HYPOTHESIS: Time of adherence of adhesive baseplate housings to the neck of a laryngectomized patient is one of the main problems that account for the low number of laryngectomy patients who benefit from hands-free speech. An external neck brace (ENB 1.0) was introduced to support peristomal fixation of adhesive baseplates. STUDY DESIGN: A prospective randomized controlled clinical cross-over trial. METHODS: A total of 28 laryngectomy patients participated in this randomized, prospective, crossover trial. All used the Provox hands-free heat and moisture exchanger (HME) valve for 1 month: 2 weeks with an ENB and 2 weeks without. RESULTS: The median lifetime of an adhesive baseplate without a brace was 52.5 minutes versus 210 minutes with a brace (P = .03). Four participants considered the ENB as "a little" bit of a welcome addition, nine as "quite a bit," and six as "very much" (79%) to improve hands-free speech. CONCLUSIONS: The ENB significantly increases the lifetime of an adhesive baseplate and therefore contributes to achieving hands-free speech for a greater number of patients with laryngectomy.

A multicenter, prospective, clinical trial evaluating a novel adhesive baseplate (Provox StabiliBase) for peristomal attachment of postlaryngectomy pulmonary and voice rehabilitation devices.

OBJECTIVES/HYPOTHESIS: Assessment of a novel adhesive baseplate (Provox StabiliBase) for heat and moisture exchanger (HME) and/or automatic speaking valve (ASV) application. STUDY DESIGN: Prospective, clinical, multicenter trial. METHODS: This was a trial in laryngectomized patients comparing their usual adhesive with the trial adhesive. Primary outcome measure was overall patient preference; additional outcome parameters possibly explaining patients' preferences were 1) patient tolerance and preference with respect to daily handling of the adhesive; 2) adhesive lifespan, and 3) voice and speech with the adhesives. Study specific questionnaires, visual analog scales, patients' diaries, and stoma assessments were used for data collection. RESULTS: In total, 58 of the 65 laryngectomized individuals entered in the study completed the trial. Patients' overall preference for the new device was high (76%; P < .001). Significantly better performance was found for the trial adhesive with respect to ease of application (P = .034), fit (P < .001), and air leakage through the adhesive (P < .001). Comfort and stoma depth correlated weakly (r = 0.297; P = .024; deeper stoma-more comfort with StabiliBase). The adhesive lifespan with HME is significantly increased (1.7 times and 15.7 hours-plus airtight use; P < .001). This longer lifespan coincided with somewhat increased dirtying of the adhesive (P = .02). There were no serious adverse events. CONCLUSIONS: The StabiliBase adhesive for peristomal attachment of HMEs and/or ASVs was preferred by 76% of study participants and showed a promising prolonged lifespan. This new device further increases the options for stoma attachment in laryngectomized individuals, and subsequently the availability of optimal voice and pulmonary rehabilitation for a larger proportion of patients.