Conectar
Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.
The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth
The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.
To evaluate the effects of diabetes mellitus (DM) and body mass index (BMI) on long-term all-cause mortality in chronic total occlusion (CTO) patients.
Retrospective, nationwide cohort study.
Swedish Coronary Angiography and Angioplasty Registry, between June 2015 and December 2021.
24 284 patients with angiographically confirmed CTO. Prior coronary artery bypass graft surgery excluded. Subgroups were defined by DM status and BMI categories (underweight, healthy weight, overweight, obesity).
Long-term all-cause mortality, assessed by Kaplan-Meier analysis and multivariable Cox proportional hazards regression.
DM was present in 30.3% of patients and conferred a 31% higher risk of mortality (HR: 1.31, 95% CI: 1.20 to 1.42; p2, lowest risk (nadir) at 32 kg/m2 and modest rise above 35 kg/m2.
In this nationwide CTO cohort, DM independently predicted higher long-term mortality, accompanied by more severe comorbidities and greater CTO complexity, and insulin therapy further elevated hazard. Overweight and obese patients had better survival, while underweight individuals had the poorest prognosis. These findings underscore the importance of individualised risk assessment and management strategies in CTO patients, particularly those with DM or low BMI.
The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.
The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).
The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).
Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.
Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.
The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.
CANN2021 is a nationwide cohort of Norwegian high school students created with the aim of addressing emerging issues in epidemiology of cannabis use through the initial surveillance and examination of its correlates, causes and consequences.
Between 25 February 2021 and 10 April 2021, a core baseline sample of 3490 students (48% boys; 11th grade 35.5%, 12th grade 31.2%, 13th grade 33.3%) from 34 high schools in Norway anonymously completed comprehensive e-surveys assessing their cannabis-related involvement and experiences. A total of 1510 (43.3%) participants (45.8% boys; 11th grade 28.9%, 12th grade 31.1%, 13th grade 40.0%) provided identifying information and consented to administrative contact entailing individual-level linkages of their survey responses to their health and census data as recorded in various national registries since 2010, thus establishing the CANN2021 registry-linkages cohort.
The core baseline sample (N=3490) was largely representative of the Norwegian high school youth between the ages of 17 and 19 years, and as such of relevance to national surveillance needs. One in five (20.3%) reported having used cannabis at least once during their lifetime; of these, 40.9% consented to registry linkages.
E-survey data from the registry cohort will be linked at the individual level to health and administrative registries such as the Norwegian Patient Registry, Education, Crime, Income and Population Registry in 2025, 2029 and 2031. The retrospective and prospective linkages of baseline e-surveys with registry data can thus be used to address a range of epidemiological and public health questions, including examination of temporal associations between various types of early cannabis involvement and putative risk and protective factors, and subsequent health and social outcomes.
Major depressive disorder (MDD) is a major global healthcare challenge. This is, in part, due to the lack of treatment response and chronic course of MDD. Such a course of illness is often termed treatment-resistant depression (TRD) and is seen in over one-third of people with MDD. Reasons for treatment resistance are not well established, nor is the definition of TRD. Duration and severity of depression, however, are associated with TRD and are also associated with cognitive deficits. Thus, TRD could be particularly prone to cognitive deficits and at heightened risk for neuroprogression. While the cognitive profile of MDD has been investigated in several systematic reviews, no systematic review of cognition in TRD exists to date. The present study will fill this gap in the literature. It is expected that TRD will show more severe cognitive deficits than generally reported in MDD and deficits in all cognitive functions are expected.
A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be performed of the databases Embase, Pubmed/MEDLINE, PsychINFO and Cochrane including peer-reviewed studies on humans using standardised cognitive tests. Pilot searching was performed in January 2025 and the full search will be commenced in June 2025, with additional searches following completion. Where sufficient data are reported, a meta-analysis comparing deficits in TRD with MDD and healthy control participants will be performed; alternatively, effects based on norms will be calculated. Meta-regression, subgroup and sensitivity analyses will be conducted to explore moderators that are sufficiently reported in the literature. The quality of studies will be assessed by the Newcastle-Ottawa Scale.
Ethical approval is not necessary to perform the study, and results will be presented at a suitable conference and published in a peer-reviewed journal.
CRD42024538898.
For several decades, mortality has decreased more rapidly among individuals with a higher socioeconomic position than among those with a lower position. This widening social inequality gap has increasingly been recognised as an important aspect of public health research and policies. The objective of this study was to examine trends in educational inequality in healthy life expectancy (HLE) in Denmark between 2010 and 2021 at the age of 30 years.
The study is a population-based study based on register data on longest attained education, standard life tables and self-reported health information from nationwide health surveys.
The study is conducted among the general adult population in Denmark.
Participants include respondents from the Danish National Health Survey and the Danish Health and Morbidity Survey in 2010, 2013, 2017 and 2021 aged ≥30 years.
Expected lifetime in good self-rated health, with no long-standing illness and with no activity limitations was estimated by Sullivan’s method, and educational inequality was expressed by the Slope Index of Inequality.
Between 2010 and 2021, educational inequality in HLE increased among both men and women for long-standing illness (5-year trend: +1.1 and +1.2 years) and activity limitations (+2.4 and +2.6 years) but remained stable among men (+0.1 year) and decreased among women (–0.3 year) for self-rated health. For the latter two indicators, the inequality gap narrowed after 2017.
Trends in educational inequality in HLE in Denmark 2010–2021 vary by health indicator. Steadily widening gaps were demonstrated for long-standing illness, while narrowing gaps were seen after 2017 for activity limitations and self-rated health. Future studies are encouraged to explore potential health risk behaviours that may explain or modify these inequality trends.
To describe self-reported treatment and exercise strategies among patients with long-lasting low back pain (LBP) 1 month after consultation at a specialised hospital-based Medical Spine Clinic and evaluate their associations with changes in pain and disability 1 and 3 months after consultation.
Prospective cohort study using questionnaire data before consultation (baseline) and 1 and 3 months after consultation.
Specialised hospital-based Medical Spine Clinic, Denmark.
1686 patients with long-lasting LBP completed the baseline questionnaire; 908 patients responded at 1 month, of them 623 responded at 3 month.
Patients were categorised by treatment (physiotherapy, chiropractic treatment, physiotherapy+chiropractic treatment and no recommended treatment) and exercise strategy (exercise continued, exercise ceased, exercise initiated and not exercising).
Pain was assessed by the numeric rating scale (NRS: 0–10), and disability was assessed by the Oswestry disability index (ODI: 0–100).
1-month postconsultation, half of the patients received no recommended treatment; most others received physiotherapy (42%). Nearly half of the patients continued exercise, 28% continued to be inactive, and 22% initiated exercise. For the population as a whole, pain changed by –0.74 (95% CI –0.90; –0.58) and –1.02 (95% CI –1.22; –0.83) points on the NRS at 1- and 3-month follow-up, respectively, and disability by –2.65 (95% CI –3.51; –1.78) and –4.48 (95% CI –5.59; –3.38) points on the ODI. Differences between treatment strategies were small. However, the two groups not exercising improved less compared with those who continued exercise when adjusted for age, sex and baseline level (order of magnitude from 0.07 to 1.18 points on the NRS and from 4.01 to 9.08 points on the ODI). For pain, these group differences were statistically significant at 1 month (p
Mean improvement was negligible, with no differences between treatment strategies. However, patients not exercising showed no or less improvement, highlighting the importance of exercise in managing long-lasting LBP.
Dyslipidaemia, affecting approximately 39% of adults worldwide, is a major risk factor for cardiovascular disease. Individuals with dyslipidaemia are often prescribed statins, which effectively lower plasma low-density lipoprotein cholesterol (LDL-C), thereby reducing the risk of cardiovascular events and mortality. Although statins lower LDL-C, emerging evidence suggests that they may counteract the beneficial adaptations to exercise in skeletal muscle mitochondria and whole-body aerobic capacity. The underlying mechanisms remain unclear, and there is a need for studies investigating how statins influence molecular adaptations to exercise. The primary objective of this study is to investigate the combined effects of statin therapy and focused exercise training on mitochondrial function and whole-body aerobic capacity in people with dyslipidaemia. The untargeted proteomic analysis will be incorporated to provide detailed insights into how statins may affect mitochondrial proteins and other muscle metabolic traits, offering molecular explanations for altered functional readouts at both the muscle and whole-body levels.
A total of 100 women and men (aged 40–65 years) diagnosed with dyslipidaemia without atherosclerotic cardiovascular disease will be enrolled in this 12-week, double-blinded, randomised, placebo-controlled trial. Participants will be randomised into one of four groups using a block randomisation approach to ensure an allocation ratio of 60:40 for exercise and non-exercise conditions, respectively. The four groups will be: (1) exercise+placebo, (2) exercise+atorvastatin (80 mg/day), (3) atorvastatin (80 mg/day) and (4) placebo. The primary outcome is mitochondrial function, measured by changes in skeletal muscle citrate synthase activity from baseline to post-intervention. Secondary outcomes include whole-body aerobic capacity (VO2peak) and proteomic analyses. Genetic analysis will be conducted to assess the role of genetic polymorphisms in individual responses to statins and exercise.
The trial has received ethical approval from the Faroe Islands Ethical Committee (2024-10) and adheres to the Declaration of Helsinki and General Data Protection Regulation (GDPR). Results will be published in peer-reviewed international journals.
Over half of children and adolescents with attention-deficit/hyperactivity disorder (ADHD) have difficulties with emotion dysregulation (EDR) and/or sleep, yet the interrelations between emotional regulation and sleep are not well-characterised in this population. This systematic review will address the relationship between these difficulties and investigate whether specific aspects of EDR are more strongly related to sleep problems in youth with ADHD.
We will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analysis guideline for systematic reviews. A wide set of electronic databases will be searched for peer-reviewed quantitative studies investigating the relationship between EDR and sleep in children and adolescents (ages 5 to 18 years) with ADHD. In addition, the reference list of all studies will be searched for other relevant studies, and Scopus will be used to search for citations of the included studies. We will also contact experts in the field to request published and unpublished studies. The primary outcome will be the effect size of the relationship between EDR and sleep in children and adolescents with ADHD. We will look at EDR and sleep broadly and also consider the multifaceted nature of both terms. Secondary outcomes will include which facets of EDR and sleep have been measured and how they have been measured, developmental differences between children and adolescents with ADHD and how—and the extent to which—studies controlled for the use of CNS medications and cooccurring disorders in their study design and/or statistical analyses. The quality and risk of bias of the included studies will be assessed using the Mixed Methods Appraisal Tool.
This protocol is for a review of studies and does not involve any new data collection and therefore does not need ethical or human subjects approval. The results will be presented at international conferences and in a peer-reviewed journal.
CRD42024612984.
Fibrotic interstitial lung diseases (F-ILD) are severe and often progressive lung disorders that frequently lead to respiratory failure, with patients experiencing high symptom burdens, including severe dyspnoea. This is also evident in patients with severe chronic obstructive pulmonary disease (COPD). Many patients will eventually require ambulatory oxygen therapy (AOT) due to exertional desaturation. Although AOT has shown benefits like increased walking distance and improved quality of life, adherence remains a challenge due to practical issues. AOT can be given by oxygen bottles that provide continuous oxygen flow or as portable concentrators; however, there is a lack of studies comparing the different methods and assessing patient preferences. Data from the present study help guide the selection of patients for different AOTs and provide information on patient preferences.
The study design is a single-centre, randomised, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. Patients with COPD or F-ILD who, during a 6-minute walk test (6MWT), can walk at least 50 m and desaturate below 88% are eligible for inclusion in the study. The participants are randomised to perform the 6MWT with either oxygen bottles or portable concentrators first. The primary endpoint is the difference in the lowest oxygen saturation (SpO2) between the two systems. Secondary endpoints include, among others, the difference in percentage of time and number of minutes when SpO2 falls below 88%, mean and maximum pulse rate, and distance and time taken to recover during the 6MWT. Quality of life and patient preferences will be evaluated by scores from the COPD assessment test and the King’s Brief Interstitial Lung Disease health status questionnaire to help gain a better understanding of symptom impact during activity and limitations in daily life.
The study has been approved by the Central Denmark Region Committees on Health Research Ethics (1-10-72-115-24). The results of this trial will be submitted for publication in an international peer-reviewed journal.
Measurement of tear film stability is central in dry eye disease (DED) diagnosis. In this study, we aimed to compare the performance of two methods of tear film stability measurement: non-invasive tear break-up time (NIBUT) and fluorescein tear film break-up time (FTBUT).
Cross-sectional study.
The study involved 132 subjects of 65-year-old inhabitants of the Oslo region who were not seeking ophthalmic care.
The participants underwent a battery of DED tests, including NIBUT measured on Oculus Keratograph 5M and a traditional method using fluorescein drops (FTBUT). Oculus Keratograph 5M measures two types of NIBUT:; appearance time of the first dry spot (NIBUTFirst) and average NIBUTAvg.
74 participants (56%) were female and 58 were male (44%). Subjects presented with varying degrees of DED signs and symptoms. Mean values of NIBUTFirst and FTBUT from all the participants were significantly different (6.2±4.9 s vs 8.6±6.2 s, pFirst and NIBUTAvg values (6.2±4.9 s vs 8.3±5.5 s, pAvg values (8.6±6.2 s vs 8.3±5.5 s, p=0.655). The receiver operating characteristic curve analysis was performed to compare NIBUT and FTBUT in regards to other clinical tests (Ocular Surface Disease Index, ocular surface staining, blink interval, eye redness, corneal sensitivity, lid debris, Schirmer I test, tear osmolarity, meibum quality, meibum expressibility, lid hyperemia, tear meniscus height. irregular lid margin, conjunctival hyperaemia, margin telangiectasia, lipid layer and meibomian gland drop-out). While FTBUT demonstrated results with area under the curve>0.6, neither NIBUTFirst nor NIBUTAvg showed significant results.
NIBUTFirst was shorter than FTBUT. Low correlation between NIBUT and FTBUT indicates that these diagnostic tests are not interchangeable. Other DED tests had correlation, though low, while NIBUT did not demonstrate correlation.
To explore how youth understand and manage risk associated with food allergy in everyday life, aiming to inform future advanced nursing and care initiatives.
Qualitative study based on critical psychological practice research.
Data was generated through participant observation and informal interviews during a 2-day camp with youth aged 18–23years (n = 10), diagnosed with food allergy in childhood. Data analysis used thematic analysis informed by a critical psychology theoretical framework.
Risk associated with food allergy is an integrated aspect of the youth life trajectories. The allergy clinic plays a crucial role in how they come to understand and manage risk. Paradoxically, knowledge of risk fosters safety as well as uncertainty. Bodily awareness plays a crucial role in managing food allergy, but minor bodily sensations can trigger anxiety and fear of anaphylaxis. Establishing routines emerges as a key strategy for managing risk, as routines reduce anxiety and facilitate participation in everyday social activities.
The study highlights the complexity of managing food allergy in the everyday life of youth. How risk knowledge is translated from the clinic into everyday life varies and impacts risk management strategies in different ways.
HCP must address both physical and psychosocial aspects of living with the risk associated with food allergy. Individually tailored risk communication that considers personal circumstances and experiences can help reduce anxiety and support strategies for managing food allergy in everyday life.
Integrating patients' everyday perspectives and risk management into healthcare fosters personalised care. Nurses and doctors should help patients bridge the gap between medical advice and its practical application, addressing both physical and emotional aspects of managing health risks.
The SRQR guideline for reporting qualitative research.
Patient representatives were involved in developing the protocol, research questions and study aims.
To explore home-dwelling people with dementia and family members' perceptions of the feasibility and acceptability of an intervention using dementia-related literature excerpts to facilitate conversations on ethical issues related to living with dementia.
Ethical issues in dementia care emerge throughout the illness. In the early stages, they may involve decisions about disclosing the illness to the family, shifting roles and responsibilities, and considerations of transitioning to a nursing home. Addressing ethical issues and providing adequate support to home-dwelling people with dementia and their families are often lacking.
An exploratory-descriptive qualitative study.
We conducted eight interviews with 14 home-dwelling persons with dementia and their family caregivers. Six were dyadic interviews, and two were individual interviews with family caregivers. We analysed the interview data using template analysis. We adhered to the COREQ checklist in reporting this study.
Using excerpts from dementia-related literature was a feasible and acceptable way of initiating discussions on ethical issues among home-dwelling persons with dementia and family caregivers. However, engaging the families of newly diagnosed individuals was challenging due to emotional distress. The intervention provided peer support, including identifying with others and sharing experiences. Moreover, participating couples found intimacy and relational attunement through shared reflections.
Based on the findings, it appears that the participants in this study felt that using excerpts from dementia-related literature to deliberate on ethical issues was feasible and acceptable. Deliberating on ethical issues with peers and family caregivers offers valuable social support and opportunities for strengthening relationships.
This study makes an important contribution by providing valuable insights into how ethical issues related to living with dementia can be addressed using related literature and suggests how the intervention can be integrated into existing care initiatives for home-dwelling people with dementia and their families.
We have adhered to relevant EQUATOR guidelines with the COREQ reporting method.
A healthcare professional working as a so-called dementia coordinator (a title used in the Danish context) was involved in the conduct of this study by being responsible for the recruitment of home-dwelling people with dementia and their family members. Moreover, she had joint responsibility for facilitating the intervention along with the first author.
To achieve an in-depth understanding of the challenges associated with diabetes management when having both schizophrenia and type 2 diabetes, while also identifying the needs for improved diabetes self-care.
The study employed a qualitative explorative design utilizing a phenomenological-hermeneutic inspired approach, involving field observations and individual semistructured interviews.
Data were collected during 2020–2021 through 17 field observations of outpatient consultations and 13 individual semistructured interviews. Data, including field notes and verbatim transcribed interviews, underwent analysis following Ricoeur's interpretive philosophy, encompassing three levels: naïve reading, structural analysis and critical interpretation and discussion. This study adheres to the COREQ guidelines for qualitative research.
Three key themes emerged: ‘Diabetes when life is noisy’, ‘Sacrifices and compromises in life’ and ‘The double silence’. Everyday life is significantly affected when having both schizophrenia and T2D. The mental health state dominates in relation to diabetes self-care and individuals experience challenges balancing between the two conditions. However, there exists a general acknowledgement for diabetes and its long-term complications as a serious medical condition demanding careful attention and treatment.
Self-managing two such complex conditions can be overwhelming and make it difficult for the individual to differentiate symptoms and prioritize diabetes care. Moreover, the existing fragmentation within healthcare systems poses communication challenges, resulting in disjointed patient pathways.
The study emphasizes the need for a holistic re that addresses the physical, emotional and social challenges. There is also a need for increased awareness and education among informal caregivers and healthcare professionals to foster better understanding and support.
To summarise, interpret and synthesize research findings on patients' and nurses' experiences of caring in nursing across clinical practices.
Caring is a universal element of nursing; however, economic restrictions often negatively impact health services, and time shortages and limited numbers of staff may characterize care encounters. It is unclear how these contextual conditions affect patients' and nurses' experiences of caring.
This integrative literature review covers papers published between 2000 and 2022. Four databases—PubMed, PsycINFO (via Ovid), MEDLINE (via Ovid) and CINAHL (via EBSCO)—were systematically searched for eligible papers in May 2022. The included studies were critically appraised. Content analysis was performed to interpret and synthesize the findings. In accordance with the EQUATOR guidelines, the PRISMA 2020 and PRISMA-S checklists were used. An Integrative review methodology guided the process.
In total, 33 studies were included in the review. Three themes captured the experiences of caring in nursing: (1) the complexity of the nursing care context, (2) the professionalism of the nurse, and (3) the trusting patient–nurse relationship.
The experience of caring in nursing depended on nurses' competence and discretion in the personal encounter framed by the nursing context. The caring relationship was based on reciprocity, but it remains asymmetrical, as the nurse had the power and responsibility to empower the patient. Barriers, such as increased demands for efficiency and resource scarcity, may hinder the experience of caring in nursing.
By promoting an ongoing discussion of caring in nursing, nurse management can systematically support nurses in reflecting on their practice in diverse and complex clinical contexts.
No patient or public contribution was made due to the study design.
There is an increasing use of non-medicated wound dressing with claims of irreversible bacterial binding. Most of the data are from in vitro models which lack clinical relevance. This study employed a range of in vitro experiments to address this gap and we complemented our experimental designs with in vivo observations using dressings obtained from patients with diabetes-related foot ulcers. A hydrophobic wound dressing was compared with a control silicone dressing in vitro. Test dressings were placed on top of a Pseudomonas aeruginosa challenge suspension with increasing concentrations of suspension inoculum in addition to supplementation with phosphate buffered saline (PBS) or increased protein content (IPC). Next, we used the challenge suspensions obtained at the end of the first experiment, where bacterial loads from the suspensions were enumerated following test dressing exposure. Further, the time-dependent bacterial attachment was investigated over 1 and 24 h. Lastly, test dressings were exposed to a challenge suspension with IPC, with or without the addition of the bacteriostatic agent Deferiprone to assess the impacts of limiting bacterial growth in the experimental design. Lastly, two different wound dressings with claims of bacterial binding were obtained from patients with chronic diabetes-related foot ulcers after 72 h of application and observed using scanning electron microscope (SEM). Bacteria were enumerated from each dressing after a 1-h exposure time. There was no statistical difference in bacterial attachment between both test dressings when using different suspension inoculum concentrations or test mediums. Bacterial attachment to the two test dressings was significantly lower (p < 0.0001) when IPC was used instead of PBS. In the challenge suspension with PBS, only the hydrophobic dressing achieved a statistically significant reduction in bacterial loads (0.5 ± 0.05 log colony forming units; p = 0.001). In the presence of IPC, there was no significant reduction in bacterial loads for either test dressing. When bacterial growth was arrested, attachment to the test dressings did not increase over time, suggesting that the number of bacteria on the test dressings increases over time due to bacterial growth. SEM identified widespread adsorption of host fouling across the test dressings which occurred prior to microbial binding. Therein, microbial attachment occurred predominantly to host fouling and not directly to the dressings. Bacterial binding is not unique to dialkylcarbamoyl chloride (DACC) dressings and under clinically relevant in vitro conditions and in vivo observations, we demonstrate (in addition to previously published work) that the bacterial binding capabilities are not effective at reducing the number of bacteria in laboratory models or human wounds.
FreshRSS 