New device, 'old' allergens. Allergic contact dermatitis caused by the Dexcom G7 glucose sensor.

BACKGROUND: Allergic contact dermatitis (ACD) has been reported as an adverse effect from the use of several glucose sensors and insulin pumps from different manufacturers. Isobornyl acrylate (IBOA) has been identified as a major culprit sensitizer, but also other acrylates and (modified) colophonium have been reported as causes of ACD. OBJECTIVES: To report the two first cases diagnosed with ACD caused by the Dexcom G7 (DG7) glucose sensor. PATIENTS AND METHODS: Two children with suspected ACD from DG7 were patch tested with our medical device series with an addition of selected test preparations including two variants of modified colophonium - methyl hydrogenated rosinate (MHR) and glyceryl hydrogenated rosinate (GHR). Both patients were also tested with acetone extracts made from different parts of the DG7 sensor. The extracts were analysed by gas chromatography-mass spectrometry (GC-MS). RESULTS: Both patients tested positive to IBOA, hydroabietyl alcohol and GHR. In addition, patient 1 had a positive reaction to MHR and patient 2 had a positive reaction to colophonium. The GC-MS analyses showed the presence of IBOA and colophonium-related substances in the DG7 extracts. CONCLUSIONS: Both patients were diagnosed with contact allergy to well-known medical device-related sensitizers. The presence of IBOA and (modified) colophonium in a newly introduced (on the Swedish market in 2023) glucose sensor is remarkable and indicates an inadequate toxicological assessment of the materials used in the sensor.

Safety and efficacy of silicone tape for indwelling urinary catheter fixation in intensive care patients-A randomized clinical trial.

BACKGROUND: Critically ill patients are more vulnerable to medical adhesive-related skin injuries (MARSI), whose prevention is a constant challenge and one of the main quality indicators of nursing care. MARSI associated with indwelling urinary catheter (IUC) fixation is a relevant adverse event, mainly because of the constant involuntary traction and high skin vulnerability of the fixation site. Silicone adhesive tape has appreciable qualities for fragile skin among the range of adhesives, leading to the inference that it reduces the risk of MARSI. AIM: To compare silicone adhesive tape for IUC fixation with acrylate tape regarding its safety and efficacy. STUDY DESIGN: This was a randomized controlled trial blinded to the patients and evaluator. Data were collected from an intensive care unit (ICU) of a tertiary university hospital in Brazil. Patients with IUC and no MARSI at the fixation site were considered eligible. The omega (Ω) fixation technique was used for IUC fixation. A total of 132 participants were enrolled and divided into two research groups: 66 patients in the intervention group (silicone tape) and 66 in the control group (acrylate tape). Outcomes were the incidence of MARSI, patient outcome in the ICU and hospital and partial, total and overall spontaneous detachment of the tapes. RESULTS: The overall incidence of MARSI was 28%, with 21% in the silicone group and 35% in the acrylate group, with no statistically significant difference (p = .121), including the severity of the lesions (p = .902). However, partial (p = .003) and overall (p < .001) detachment of the tapes were more frequent in the silicone group. CONCLUSIONS: Silicone tape is no safer than acrylate tape for IUC fixation and is less adhesively effective. RELEVANCE TO CLINICAL PRACTICE: There is no evidence to support the extensive use of silicone tape in this context.

Evaluating the Irritant Factors of Silicone and Hydrocolloid Skin Contact Adhesives Using Trans-Epidermal Water Loss, Protein Stripping, Erythema, and Ease of Removal.

A composite silicone skin adhesive material was designed to improve its water vapor permeability to offer advantages to wearer comfort compared to existing skin adhesive dressings available (including perforated silicone and hydrocolloid products). The chemical and mechanical properties of this novel dressing were analyzed to show that it has a high creep compliance, offering anisotropic elasticity that is likely to place less stress on the skin. A participant study was carried out in which 31 participants wore a novel silicone skin adhesive (Sil2) and a hydrocolloid competitor and were monitored for physiological response to the dressings. Trans-epidermal water loss (TEWL) was measured pre- and postwear to determine impairment of skin barrier function. Sil2 exhibited a higher vapor permeability than the hydrocolloid dressings during wear. Peel strength measurements and dye counter staining of the removed dressings showed that the hydrocolloid had a higher adhesion to the participants' skin, resulting in a greater removal of proteins from the stratum corneum and a higher pain rating from participants on removal. Once the dressings were removed, TEWL of the participants skin beneath the Sil2 was close to normal in comparison to the hydrocolloid dressings that showed an increase in skin TEWL, indicating that the skin had been highly occluded. Analysis of the skin immediately after removal showed a higher incidence of erythema following application of hydrocolloid dressings (>60%) compared to Sil2, (<30%). In summary, this modified silicone formulation demonstrates superior skin protection properties compared to hydrocolloid dressings and is more suitable for use as a skin adhesive.

A temperature-sensitive, high-adhesion medical tape: a comparative, single-blind clinical trial.

OBJECTIVE: Medical adhesives are used to secure wound care dressings and other critical devices to the skin. While high peel-strength adhesives provide more secure skin attachment, they are difficult to remove from the skin and are correlated with medical adhesive-related skin injuries (MARSI), including skin tears, and an increased risk of infection. Lower-adhesion medical tapes may be applied to avoid MARSI, leading to dressing or device dislodgement and further medical complications. METHOD: This paper reports on the clinical testing of a new, high-adhesion medical tape, ThermoTape (University of Washington, US), designed for low skin trauma upon release. ThermoTape was benchmarked with Tegaderm (3M, US) and Kind Removal Tape (KRT) (3M, US). All three tapes were applied to both the left and right forearm of healthy volunteers and were removed 24 hours later-the right arm without applying heat and the left arm by applying a heat pack for 30 seconds before removal. Tape wear, self-reported pain (0-10 scale) and skin redness 15 minutes after removal were recorded. RESULTS: This was a 53-subject comparative, single-blind clinical trial. There were clinically and statistically significant results supporting reduced pain during removal of ThermoTape with warming, with an average 58% decrease in pain, paired with a statistically significant 45% reduction in skin redness (p<0.01 for both values). In contrast, there were statistically insignificant differences in pain and redness for removal of Tegaderm and KRT with warming. ThermoTape after warming, in comparison with Tegaderm without warming, produced a reduced pain score of >1 on the 0-10 Wong-Baker/Face pain scale, which was statistically significant (p<0.01). CONCLUSION: These results provide compelling evidence that warming ThermoTape prior to removal can reduce pain and injury when compared with standard medical tapes. This could allow for stronger attachment of wound care dressings and critical medical devices while reducing cases of MARSI.

Incidence and Predictive Model of Medical Adhesive-Related Skin Injury in Cancer Patients Managed With Central Venous Access Devices: A Retrospective Study.

PURPOSE: The purpose of this study was to determine the prevalence of medical adhesive-related skin injury (MARSI) at the site of central venous access device (CVAD) implantation in patients with cancer, identify risk factors associated with MARSI in patients with cancer, and create a nomogram for predicting risk of MARSI. DESIGN: Retrospective, single-center study. SUBJECTS AND SETTING: The sample comprised 1172 consecutive patients who underwent CVAD implantation between February 2018 and February 2019; their mean age was 55.7 years (SD: 13.9). Data were collected at the First Affiliated Hospital of Xi'an Jiaotong University, located in Xi'an, China. METHODS: Demographic and pertinent clinical data were collected from patient records. Routine dressing changes were performed every 7 days for peripherally inserted central venous catheters (PICCs) or 28 days for ports except in patients with existing skin injuries. Skin injuries related to use of medical adhesives and persisting for more than for 30 minutes were classified MARSI. Data were used to develop a nomogram for predicting MARSI. The accuracy of the nomogram was verified by calculating the concordance index (C-index) and drawing a calibration curve. RESULTS: Among the 1172 patients, 330 (28.2%) had undergone PICC implantation, and 282 (24.1%) experienced 1 or more MARSIs representing an incidence rate of 1.7 events per 1000 CVAD days. Statistical analysis identified previous MARSI history, the need for total parenteral nutrition support, other catheter-related complications, a history of allergy, and PICC implantation as associated with a higher likelihood of developing for MARSI. Based on these factors, we established a nomogram for predicting the risk of developing MARSI in patients with cancer who underwent CVAD implantation. The C-index of the nomogram was 0.96, and the calibration curve of the nomogram showed that the predictive ability of the nomogram was strong. CONCLUSIONS: We evaluated patients with cancer who were undergoing CVAD and identified that previous MARSI history, patients needing total parenteral nutrition support, other catheter-related complications, allergic history, and PICC implantation (compared with ports) were associated with a higher likelihood for developing MARSI. The nomogram we developed showed a good ability for predicting the risk of developing MARSI and may assist nurses to predict MARSI in this population.

The prevalence of medical adhesive-related skin injury caused by protective dressings among medical staff members during the 2019 coronavirus pandemic in China.

AIM: To explore the prevalence and risk factors for medical adhesive-related skin injury (MARSI) caused by protective dressings among medical staff members during the 2019 coronavirus disease pandemic (COVID-19) in China. MATERIALS AND METHODS: A cross-sectional survey was conducted using a questionnaire. The questionnaire was released through the Questionnaire Star website and was completed online. The prevalence of MARSI was calculated and risk factors were analyzed using a multiple regression model. RESULTS: A total of 414 front-line medical staff members treating COVID-19 patients were enrolled from 46 hospitals across four provinces and two municipalities. Overall, 83.1% used protective medical adhesive dressings applied to the head and face to prevent skin damage from personal protective equipment. The prevalence of MARSI caused by adhesive dressings was 41.9%. By multiple regression analysis, the type of dressing, duration of dressing usage, and pain score were risk factors for MARSI development. CONCLUSIONS: The high prevalence indicates MARSI is common among front-line medical staff members, especially those using hydrocolloid dressings and longer durations of dressing usage. Pain upon dressing removal can be severe and increased the risk of MARSI. We call for paying more attention to MARSI and recommend multisite studies with larger sample sizes to enhance the generalizability of these findings.

The Science of Skin: Measuring Damage and Assessing Risk.

Significance: Healthy skin provides a barrier to contaminants. Breaches in skin integrity are often encountered in the patient health care journey, owing to intrinsic health issues or to various procedures and medical devices used. The time has come to move clinical practice beyond mere awareness of medical adhesive-related skin injury and toward improved care and outcomes. Recent Advances: Methods developed in research settings allow quantitative assessments of skin damage based on the measurement of baseline skin properties. These properties become altered by stress and over time. Assessment methods typically used by the cosmetic industry to compare product performance could offer new possibilities to improve clinical practice by providing better information on the status of patient skin. This review summarizes available skin assessment methods as well as specific patient risks for skin damage. Critical Issues: Patients in health care settings may be at risk for skin damage owing to predisposing medical conditions, health status, medications taken, and procedures or devices used in their treatment. Skin injuries come as an additional burden to these medical circumstances and could be prevented. Technology should be leveraged to improve care, help maintain patient skin health, and better characterize functional wound closure. Future Directions: Skin testing methods developed to evaluate cosmetic products or assess damage caused by occupational exposure can provide detailed, quantitative information on the integrity of skin. Such methods have the potential to guide prevention and treatment efforts to improve the care of patients suffering from skin integrity issues while in the health care system.

Medical adhesive-related skin injury in adult intensive care unit: scoping review.

OBJECTIVES: to identify and synthesize scientific evidence on preventing medical adhesive-related skin injuries in adult intensive care patients. METHODS: this is a scoping review based on PRISMA-ScR recommendations and the technique proposed by Joanna Briggs Institute. PubMed, CINAHL, Web of Science, Scopus, LILACS, and Embase databases were searched using "Injuries AND Adhesives AND Skin AND Medical" descriptors". RESULTS: 1,329 studies were identified, and after analysis, the final sample consisted of nine articles. We obtained two experts' consensus, three case studies, two cross-sectional studies, one prospective cohort study, and one literature review regarding the type of studies. FINAL CONSIDERATIONS: the synthesized evidence allowed us to list health care measures to prevent medical adhesive-related skin injuries. The professional must know how to identify the skin injuries associated with medical adhesives and the main strategies for their prevention.

Nonoccupational Allergic Contact Dermatitis to 4-Acryloylmorpholine in Smartwatch Screen Protectors Glue.

BACKGROUND: We recently identified an outbreak of occupational allergic contact dermatitis (ACD) involving workers of a Spanish company selling smartphone protective cases from a glue product. A chemical analysis of one glue sample revealed the presence of 4-acryloylmorpholine among other allergens.The same glue is also used to attach tempered glass protective cases to Apple smartwatches. OBJECTIVE: Our objective was to describe a case series of nonoccupational consumer ACD from the previously mentioned Apple smartwatch protective case glue. METHODS: We evaluated epidemiological and clinical data, as well as patch tests results. RESULTS: Three women were diagnosed with nonoccupational ACD from the adhesive. An annular vesicular inflammatory plaque involving the dorsal aspect of the wrist was initially observed in all. Two of the 3 patients were patch tested with 4-acryloylmorpholine 0.5% with positive strong reactions. Both also strongly reacted to a sample of the glue semiopen tested in a drop of petrolatum. One of them was also positive for various acrylates. CONCLUSIONS: 4-Acryloylmorpholine has been identified in an adhesive used to attach protective cases to smartwatches. Nonoccupational ACD have been described to involve consumers of smartwatches. A UV-curable adhesive used to attach protective cases to smartwatches has been considered to be the culprit.

Contact dermatitis in children caused by diabetes devices.

BACKGROUND: Insulin pumps and glucose monitoring devices improve diabetes mellitus control and enhance patients' quality of life. However, a growing number of adverse cutaneous reactions related to the use of these devices have been reported. OBJECTIVE: To investigate the culprits of localized contact dermatitis in paediatric patients with diabetes caused by insulin pumps and glucose monitoring devices. METHODS: Retrospective analysis of 15 paediatric patients patch tested as part of a clinical investigation for skin reactions associated with insulin pumps and glucose monitoring devices. RESULTS: Seven patients had positive patch test reactions to isobornyl acrylate (IBOA) and five had positive reactions to benzoyl peroxide (BP). Positive patch test reactions to materials from the glucose sensor and/or insulin pump were seen in 10 of the 15 patients. Three had positive reactions to adhesive remover wipe from Smith and Nephew Remove and four had reactions to EMLA plaster. CONCLUSION: A high share of patients showed positive reactions to IBOA and/or their medical devices (insulin pumps or glucose devices). A third of patients showed positive reactions to BP. The presence of additional unidentified allergens cannot be excluded, highlighting the importance of access to a full description of the chemical composition of the devices.

Contact allergy to the Dexcom G6 glucose monitoring system-Role of 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate in the new adhesive.

BACKGROUND: Skin reactions to the glucose monitoring systems Dexcom G5 and G6 have been rare. In 2019, the components of the adhesive were exchanged for better skin fixation. Since then, more and more patients experienced severe skin reactions. A few months ago, 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) was identified as a new component in the adhesive of the G6 model. Furthermore, it was suspected that isobornyl acrylate (IBOA) was also a component of the exchanged adhesive. OBJECTIVES: Our objective was to investigate if MBPA plays a major role in the increasing skin problems of patients without a history of IBOA-sensitization. Furthermore, our aim was to examine whether IBOA is contained in the newer model adhesive and may also contribute to allergic contact dermatitis (ACD). PATIENTS AND METHODS: Five patients with a newly occurred ACD caused by the glucose monitoring system Dexcom G6 were investigated. Patch testing including MBPA in three different concentrations, as well as IBOA, were performed. Gas chromatography-mass spectrometry of the newer system Dexcom G6 was carried out. RESULTS: All patients were shown to be sensitized to MBPA, while MBPA 0,5% showed the strongest reaction. On the other hand, IBOA was tested negative. CONCLUSION: In our study group, MBPA was observed to be the triggering allergen of the recently changed adhesive.

Medical adhesive-related skin injuries in the neonatology department of a teaching hospital.

BACKGROUND: Medical adhesives are used to affix components to the skin. They are part of procedures performed by medical specialties because of their participation as constituents of different products, such as tapes, dressings, and electrodes. AIM: This study aims to assess the prevalence of, and factors associated with, the development of medical adhesive-related skin injuries (MARSIs) in patients treated with medical tapes in the neonatology department of a large teaching hospital in Brazil. STUDY DESIGN: Cohort study. METHODS: All premature newborns (gestational age from 28 to <37 weeks) admitted in the neonatal intensive care unit of a teaching hospital, from March to August 2019, were followed up. Neonate skin condition was assessed based on the Neonatal Skin Condition Scale (NSCS). Data analyses were conducted in R software. RESULTS: In total, 46 premature newborns were included in the study; 552 evaluations were performed-mean of 11.7 per patient. Most neonates (n = 41; 89.1%) used adhesive tapes, either paper tape (n = 37; 80.4%) or transparent film dressing (n = 34; 73.9%). Newborns' face and head were the most affected body regions (n = 125; 50.2%). Eight patients had MARSIs (19.5% of patients who used tape). NSCS scores (P value <.001) and the adopted warming system (P value = .01302) were associated with the occurrence of MARSIs. Incubators seem to be a protective factor for MARSI (OR = 0.048; IC95% = 0.0008-0.75; P value = .013). CONCLUSION: Adhesive tapes in premature newborns should be considered a risk factor for injuries. Although NSCS showed mild-to-moderate impairment and lesion severity was low, this event is relatively frequent in neonatal units. RELEVANCE TO CLINICAL PRACTICE: Awareness of the risk associated with adhesive tape application and removal in newborns allow health services to better address the problem by enforcing good practices, elaborating better protocols, qualifying the health care professionals, and potentially selecting softer tapes for neonates.

Randomized, double-blind, two-way crossover bioequivalence and adhesion study, in healthy women, of a transdermal contraceptive patch with a newly sourced adhesive component at the end of shelf life vs. the EVRA patch at the beginning of shelf life.

OBJECTIVE: Evaluate bioequivalence, based on norelgestromin (NGMN) and ethinyl estradiol (EE) plasma concentrations, and adhesion of a transdermal contraceptive patch containing a newly sourced adhesive component (test) at end of shelf life (EOSL) vs. the marketed EVRA patch (reference) at beginning of shelf life (BOSL). MATERIALS AND METHODS: In this randomized, double-blind, two-way crossover study, healthy women received a single, 7-day application of test and reference patches in 4 sequences: two 11-day treatment periods separated by a 21-day washout. Assessments included NGMN and EE pharmacokinetics (PK), adhesion (per European Medicines Agency (EMA) 5-point scale), irritation potential and application-site reactions, and tolerability. Patches were bioequivalent if 90% CIs of geometric mean ratios (GMRs) of test/reference for Cmax, AUC168h, AUC0-tlast, and AUC∞ were 80 - 125%. Patch adhesion was comparable if ratios of geometric mean cumulative adhesion percentages were ≥ 90%. RESULTS: 68 women were randomized, and 62 completed both treatments. 55 and 59 participants in the reference and test group, respectively, had patch adhesion ≥ 80% (EMA score 0 - 1) at end of treatment. Bioequivalence was demonstrated: GMRs for pharmacokinetic (PK) parameters ranged from 102.76 - 105.57% for NGMN and 93.78 - 94.80% for EE, and associated 90% CIs were fully within the bioequivalence acceptance range (80 - 125%) for both. The patches had comparable adhesion properties (GMR, 101.4% (90% CI: 99.2 - 103.6)) and incidences of treatment-emergent adverse events. CONCLUSION: NGMN-EE transdermal test patch at EOSL was bioequivalent to the marketed patch at BOSL, supporting widening the product's shelf-life specification. Adhesive properties and safety profiles were comparable between patches.