Reduction in lower urinary tract mucosal microtrauma as an effect of reducing eyelet sizes of intermittent urinary catheters.

Intermittent catheterization (IC) utilizing conventional eyelets catheters (CECs) for bladder drainage has long been the standard of care. However, when the tissue of the lower urinary tract comes in close proximity to the eyelets, mucosal suction often occurs, resulting in microtrauma. This study investigates the impact of replacing conventional eyelets with a drainage zone featuring multiple micro-holes, distributing pressure over a larger area. Lower pressures limit the suction of surrounding tissue into these micro-holes, significantly reducing tissue microtrauma. Using an ex vivo model replicating the intra-abdominal pressure conditions of the bladder, the intra-catheter pressure was measured during drainage. When mucosal suction occurred, intra-catheter images were recorded. Subsequently affected tissue samples were investigated histologically. The negative pressure peaks caused by mucosal suction were found to be very high for the CECs, leading to exfoliation of the bladder urothelium and breakage of the urothelial barrier. However, a micro-hole zone catheter (MHZC) with a multi-eyelet drainage zone showed significantly lower pressure peaks, with over 4 times lower peak intensity, thus inducing far less extensive microtraumas. Limiting or even eliminating mucosal suction and resulting tissue microtrauma may contribute to safer catheterizations in vivo and increased patient comfort and compliance.

Catheter-associated bladder mucosal trauma during intermittent voiding: An experimental study in pigs.

Objective: The objective of this study is to characterize bladder mucosal trauma associated with intermittent catheterization with conventional eyelet catheters (CECs) and to assess if a microhole zone catheter (MHZC) design concept reduces this adverse effect. Materials and Methods: A porcine model was developed to reflect human catheterization and bladder drainage. Nine pigs were randomized for catheterization with CEC (n = 6) or MHZC (n = 3). The bladder was drained repeatedly 20 times through the catheter. Cystoscopy was performed before and after the procedure, and bladders were analysed by histopathology. Two additional pigs were used for cystoscopy visualization of suction events in vivo. Cystoscopy, gross pathology, histopathological score, leucocyte infiltration, and intracatheter pressure at flow stops during voiding were compared for each group. Results: A significant higher pressure gradient was measured inside the CECs compared with MHZCs during flow stop. Consequently, CECs resulted in suction events inflicting bladder trauma characterized by loss of epithelium, oedema, haemorrhage, and neutrophil tissue infiltration. No significant trauma was identified when using MHZC. Conclusions: Considerable mucosal bladder trauma is inflicted by CECs which may be an overlooked risk factor for urinary tract infection. Catheters can be designed to minimize mucosal suction and reduce associated trauma. This may be a solution to reduce infection frequency and increase user comfort. Furthermore, the study demonstrates the potential of pigs as an attractive animal model for investigating urinary catheter performances.

New micro-hole zone catheter reduces residual urine and mucosal microtrauma in a lower urinary tract model.

Urinary tract infections (UTIs) are the main complication associated with clean intermittent catheterization (CIC) and are facilitated by post-void residual urine and trauma to the mucosa during voiding. The risk of UTI may be diminished by reducing the residual volumes and preventing microtrauma caused by mucosal suction through the eyelets of conventional eyelet catheters (CEC). A new micro-hole zone catheter (MHZC) was developed and tested in an ex vivo porcine lower urinary tract model and in vivo, in pigs, against a CEC. It was shown that, irrespective of the micro-hole diameter, the new catheter ensured increased flowrates and significantly lower residual volumes at the first flow-stop. Furthermore, with a micro-hole diameter of 0.4 mm, mucosal suction was virtually eliminated, regardless of the insertion depth or simulated intra-abdominal pressure mimicking sitting or standing humans. Pressure profile experiments and endoscopy studies indicated that the bladder gradually folds against the drainage tip of the new catheter, without blocking the flow, and, unlike with the CEC, sharp pressure variations and flow-stops did not occur during voiding. The MHZC outperformed the CEC in all tested scenarios and decreased residual volumes, thus potentially decreasing the risk of UTIs.

Skin and Artificial Skin Models in Electrical Sensing Applications.

Skin electrical properties play a significant role in recording biopotentials by using electrophysiological sensors. To test and evaluate sensor systems, it is commonly accepted to employ artificial skin models due to complications associated with testing on living tissues. The first goal of this Review is to provide a systematic understanding of the relation between skin structure and skin electrochemical behavior at an appropriate depth for electrophysiological sensing applications through a focus on skin structure, electrochemical properties of skin, and theoretical models (equivalent circuits) representing skin electrochemical behavior. The second goal is to review artificial skin models mimicking the electrochemical properties of skin and to give suggestions for future studies on relevant skin models based on a comparison between the behavior of skin and that of artificial skin models. The Review aims to help the reader to analyze the relation between the structure, elements of the equivalent circuits, and the resulting impedance data for both skin and artificial skin models.

The Ostomy Skin Tool 2.0: a new instrument for assessing peristomal skin changes.

BACKGROUND: Peristomal skin complications (PSCs) are frequently reported postoperative complications. PSCs can present visibly or as symptoms such as pain, itching or burning sensations. AIM: To develop a new tool that can capture a range of sensation symptoms together with visible complications and an objective assessment of discolouration in the peristomal area. METHOD: Consensus from qualitative interviews with health professionals and people with an ostomy, and input from expert panels, formed the basis of a patient-reported outcome (PRO) questionnaire. A decision tree model was used to define a combined score including PRO and objectively assessed discolouration area. FINDINGS: Six elements were included in the PRO questionnaire and four health states representing different severity levels of the peristomal skin were defined. CONCLUSION: The Ostomy Skin Tool 2.0 is a sensitive tool that can be used to follow changes in the peristomal skin on a regular basis and thereby help prevent severe PSCs.

Perception of leakage: data from the Ostomy Life Study 2019.

BACKGROUND: Leakage is a common problem for people with a stoma. AIM: To investigate how people with a stoma and stoma care nurses perceive different patterns of effluent under the baseplate. METHODS: The Ostomy Life Study 2019 included a user survey and a nurse survey covering experiences of leakage and the perception of leakage. FINDINGS: Most people with a stoma perceived effluent reaching outside the baseplate as leakage (88-90%), whereas effluent close to the stoma only was not perceived as leakage by the majority (81-91%). Effluent covering major parts of the baseplate was perceived as leakage by most respondents with a colostomy or ileostomy (83%), whereas fewer respondents with a urostomy perceived this as leakage (57%). Most of the nurses (70%) did not perceive effluent close to the stoma as leakage. CONCLUSION: This study revealed that effluent confined to the area next to the stoma is generally not perceived as leakage.

A Porcine Model for Urinary Tract Infection.

Urinary tract infection (UTI) is the most common bacterial infectious disease with a high frequency of recurrence and the leading cause of septicemia. In vivo experimentation has contributed significantly to the present-day knowledge on UTI pathogenesis. This research has traditionally been based on murine models of UTI. Occasional conflicting results between UTI in mice and humans and increasing skepticism toward small rodent models in general warrant the need of novel large-animal infection models that better resemble the anatomy and physiology of humans, and thus better mimic the course of infection in humans. Here, we report, to our knowledge, the first large-animal model of cystitis. The model is based on pigs, and the protocol supports the establishment of persistent, non-ascending infection in this animal and is established without invasive surgical procedures, pain, and discomfort for the animal. The course of infection is monitored by cystoscopy, microscopy of bladder biopsies, and biochemical analysis of urine and blood samples. At termination, harvested whole bladders from infected pigs are analyzed for microbiological colonization using microscopy, histology, and viable bacterial counts. The model is a useful tool in future studies of UTI pathogenesis and opens up novel possibilities to bridge the current knowledge obtained from small-animal UTI models to UTI pathogenesis in humans.

Design and characterization of core-shell mPEG-PLGA composite microparticles for development of cell-scaffold constructs.

Appropriate scaffolds capable of providing suitable biological and structural guidance are of great importance to generate cell-scaffold constructs for cell-based tissue engineering. The aim of the present study was to develop composite microparticles with a structure to provide functionality as a combined drug delivery/scaffold system. Composite microparticles were produced by incorporating either alginate/dermatan sulfate (Alg/DS) or alginate/chitosan/dermatan sulfate (Alg/CS/DS) particles in mPEG-PLGA microparticles using coaxial ultrasonic atomization. The encapsulation and distribution of Alg/DS or Alg/CS/DS particles in the mPEG-PLGA microparticles were significantly dependent on the operating conditions, including the flow rate ratio (Qout/Qin) and the viscosity of the polymer solutions (Vout, Vin) between the outer and the inner feeding channels. The core-shell composite microparticles containing the Alg/DS particles or the Alg/CS/DS particles displayed 40% and 65% DS release in 10 days, respectively, as compared to the DS directly loaded microparticles showing 90% DS release during the same time interval. The release profiles of DS correlate with the cell proliferation of fibroblasts, i.e. more sustainable cell growth was induced by the DS released from the core-shell composite microparticles comprising Alg/CS/DS particles. After seeding fibroblasts onto the composite microparticles, excellent cell adhesion was observed, and a successful assembly of the cell-scaffold constructs was induced within 7 days. Therefore, the present study demonstrates a novel strategy for fabrication of core-shell composite microparticles comprising additional particulate drug carriers in the core, which provides controlled delivery of DS and favorable cell biocompatibility; an approach to potentially achieve cell-based tissue regeneration.

Biodegradable nanocomposite microparticles as drug delivering injectable cell scaffolds.

Injectable cell scaffolds play a dual role in tissue engineering by supporting cellular functions and delivering bioactive molecules. The present study aimed at developing biodegradable nanocomposite microparticles with sustained drug delivery properties thus potentially being suitable for autologous stem cell therapy. Semi-crystalline poly(l-lactide/dl-lactide) (PLDL70) and poly(l-lactide-co-glycolide) (PLGA85) were used to prepare nanoparticles by the double emulsion method. Uniform and spherical nanoparticles were obtained at an average size of 270-300 nm. The thrombin receptor activator peptide-6 (TRAP-6) was successfully loaded in PLDL70 and PLGA85 nanoparticles. During the 30 days' release, PLDL70 nanoparticles showed sustainable release with only 30% TRAP-6 released within the first 15 days, while almost 80% TRAP-6 was released from PLGA85 nanoparticles during the same time interval. The release mechanism was found to depend on the crystallinity and composition of the nanoparticles. Subsequently, mPEG-PLGA nanocomposite microparticles containing PLDL70 nanoparticles were produced by the ultrasonic atomization method and evaluated to successfully preserve the intrinsic particulate properties and the sustainable release profile, which was identical to that of the nanoparticles. Good cell adhesion of the human fibroblasts onto the nanocomposite microparticles was observed, indicating the desired cell biocompatibility. The presented results thus demonstrate the development of nanocomposite microparticles tailored for sustainable drug release for application as injectable cell scaffolds.

Tissue response to a new type of biomaterial implanted subcutaneously in rats.

INTRODUCTION AND HYPOTHESIS: A new type of resorbable biomaterial intended for pelvic reconstruction was tested with respect to tissue regeneration and biocompatibility in rats. The biomaterial consisted of methoxypolyethyleneglycol-poly(lactic-co-glycolic acid) (MPEG-PLGA). Implants were pure, enriched with extra-cellular matrix (ECM) or estrogen. METHODS: Ten implants of each type were tested for 3 and 8 weeks, respectively. Histological assessment of connective tissue organization, inflammation, vascularization, and thickness of regenerated tissue was undertaken. RESULTS: All implants had a high degree of biocompatibility. ECM-enriched implants had significantly higher inflammatory scores compared to pure implants at 3 weeks. At 8 weeks, neither of the parameters differed significantly. No trace of the implants remained. CONCLUSIONS: The MPEG-PLGA is highly biocompatible, degrades quickly, and seems inert in the process of tissue regeneration. Thus, it is hardly a candidate per se in reinforcement of pelvic reconstruction, but it could have a future role as carrier for stem cells.

Skin changes induced by a zinc oxide dressing compared with a hydrocolloid dressing in healthy individuals.

BACKGROUND/PURPOSE: Incidence of skin complications in ostomy patients constitutes a well-known and well-described problem. The reasons are, however, very difficult to describe because of the many factors contributing to the problem. This article describes the skin changes derived exclusively from the adhesives used in a carefully controlled, long-term study using two fundamentally different types of adhesives: a hydrocolloid adhesive and a zinc oxide adhesive. METHODS: The adhesives were changed daily on the volar forearm of 11 volunteers for a 4-week period. Once a week, transepidermal water-loss (TEWL), water content of the skin, erythema and the peel force applied for removal of the adhesives were measured. On the last day of the study, a replica of the skin surface was obtained to determine changes in the skin topography, and a biopsy was taken to study changes at the cellular level. RESULTS AND CONCLUSION: We found increased TEWL and decreased water content in skin treated with the zinc oxide adhesive, but increased water-loss and water content when the hydrocolloid adhesive was used. In addition, the area treated with zinc oxide adhesive showed significant increase of epidermal thickness, scaly appearance and parakeratosis with similarities to pathological dry skin diseases such as psoriasis and atopic dermatitis, changes that were not found when using the hydrocolloid adhesive. The skin response seems to be the result of the content of zinc oxide and the mechanical interaction of the zinc oxide adhesive. We conclude that the nature of the adhesive plays an important role in the skin response to repeated application of adhesives, as seen in peristomal skin.

Exploratory multivariate spectroscopic study on human skin.

BACKGROUND/AIMS: Spectroscopy on human skin is a field that is being adopted increasingly because of its rapidity and high reproducibility. Infrared reflectance (IR), near-infrared reflectance (NIR), and fluorescence spectroscopy have previously been applied to human skin in vivo to compare healthy and sick skin, including skin cancer, atopy, and leprosy. Exploratory data analysis/chemometrics is a tool for evaluating multivariate data such as spectroscopic measurements. The objective of this study was to explore the spectral variance spanned by people with normal integument, and to demonstrate the advantages of multivariate analysis to skin research. METHODS: IR, NIR and fluorescence spectroscopy have been carried out in vivo on 216 volunteers' forearms before and after four tape strippings. The subjects were asked to fill in a questionnaire regarding factors suspected to influence the measurement results. Principal Component Analysis (PCA) was used to investigate whether the population can be divided into groups on the basis of their skin chemistry. Unless otherwise stated, the results are from the measurements prior to stripping. RESULTS: In contrast to IR and fluorescence spectra, NIR spectra proved able to detect gender differences. By use of PCA, classifications on male and female subjects were observed from the IR and NIR measurements, and as an indication from the fluorescence measurements. The NIR and fluorescence measurements varied between elderly and young subjects. The largest variance in the fluorescence landscapes was seen between pigmented and non-pigmented skin. No connection was found between the spectroscopic measurements and smoking or drinking habits. CONCLUSIONS: Future spectroscopic skin investigations should be balanced as regards to gender and age, as these can possibly affect the measurement results. Chemometrics proved to be superior to traditional attempts of interpreting the spectra.