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Journal of Immunology Research 2022Breast implants are commonly placed postbreast cancer reconstruction, cosmetic augmentation, and gender-affirming surgery. Breast implant illness (BII) is a systemic... (Review)
Review
BACKGROUND
Breast implants are commonly placed postbreast cancer reconstruction, cosmetic augmentation, and gender-affirming surgery. Breast implant illness (BII) is a systemic complication associated with breast implants. Patients with BII may experience autoimmune symptoms including fatigue, difficulty concentrating, hair loss, weight change, and depression. BII is poorly understood, and the etiology is unknown. The purpose of this literature review is to characterize BII autoimmune disorders and determine possible causes for its etiology.
METHODS
The PubMed, Google Scholar, Embase, Web of Science, and OVID databases were interrogated from 2010 to 2020 using a query strategy including search term combinations of "implants," "breast implant illness," "autoimmune," and "systemic illness."
RESULTS
BII includes a spectrum of autoimmune symptoms such as fatigue, myalgias/arthralgias, dry eyes/mouth, and rash. A review of epidemiological studies in the past ten years exhibited evidence affirming an association between breast implants and autoimmune diseases. The most commonly recognized were Sjogren's syndrome, rheumatoid arthritis, systemic sclerosis, chronic fatigue syndrome, and Raynaud's syndrome. Explantation resulted in alleviation of symptoms in over 50% of patients, strengthening the hypothesis linking breast implants to BII. Studies have shown that silicone is a biologically inert material and unlikely to be the cause of these symptoms. This is supported by the fact that increased risk of autoimmune disease was also reported in patients with other implantable biomaterials such as orthopedic implants. Recent studies shed light on a possible role of bacterial biofilm and subsequent host-pathogen interactions as a confounding factor to this problem.
CONCLUSION
BII could be dependent on biofilm infection and the microenvironment around the implants. The true pathophysiology behind these complaints must be further investigated so that alternative treatment regimens other than explantation can be developed. Translational significance of these studies is not limited to breast implants but extends to other implants as well.
Topics: Arthritis, Rheumatoid; Autoimmune Diseases; Breast Implantation; Breast Implants; Humans; Silicones
PubMed: 35571560
DOI: 10.1155/2022/8536149 -
International Journal of Nursing Studies Mar 2022There is need for improvement in effective pressure ulcers preventive strategies. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
There is need for improvement in effective pressure ulcers preventive strategies.
OBJECTIVE
To study whether a multi-layer silicone-adhesive polyurethane foam dressing shaped for the sacrum prevents PUs development in addition to standard PU preventive care for at-risk hospitalized patients.
DESIGN
Open-label, parallel group, multi-center randomized controlled trial.
PARTICIPANTS AND SETTING
709 in-hospital patients at risk for pressure ulcers from 25 medical, surgical, and intensive care units of 12 Italian hospitals.
METHODS
A multi-layer silicone-adhesive polyurethane foam was applied to the sacrum in addition to standard PUs preventive care in the intervention group. In the control group, standard preventive care alone, including systematic pressure ulcer risk assessment, skin assessment three times per day, routine positioning every 4 h, use of active support surface as appropriate, and incontinence skin care, was guaranteed. Primary outcome was incidence of sacral pressure ulcers of any stage at seven days from hospital admission. Secondary outcomes were incidence of sacral pressure ulcers ≥ II stage, number of days needed to PU development, number of skin adverse events due to the foam dressing, number of dressings used for each patient, number of withdrawing patients due to discomfort caused by the foam dressing. Participants were evaluated at baseline and at seven days.
RESULTS
In patients admitted to medical units, 15/113 controls and 4/118 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 9.2%; NNT for benefit 11, 95% CI 6 to 44). In patients admitted to surgical units, 21/144 controls and 8/142 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 8.9%; NNT for benefit 11 95% CI 6 to 49). Pressure ulcers incidence was not significantly different between the randomization arms (5.2% experimental vs 10.4% control, p = 0.141) in patients admitted to intensive care units. Overall, 46/358 (12.8%) controls and 17/351 (4.8%) in the intervention group developed sacral pressure ulcers (p<0.001; absolute reduction 8%; number needed to treat (NNT) for benefit 12, 95% CI 8 to 26). Incidence of sacral pressure ulcers ≥ II stage did not differ significantly between the two groups. No adverse skin reactions and discomfort attributable to the foam application were reported.
CONCLUSION
A sacral multi-layer silicone-adhesive polyurethane foam in addition to standard preventive care is effective for pressure ulcers prevention in at-risk hospitalized patients admitted to medical and surgical units.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03900455. The registration (April 1st, 2019) occurred before the first patient was enrolled (October 21st, 2019).
Topics: Adhesives; Bandages; Humans; Polyurethanes; Pressure Ulcer; Silicones
PubMed: 35124474
DOI: 10.1016/j.ijnurstu.2022.104172 -
Advances in Wound Care Dec 2020To determine whether multilayer silicone foam dressings can prevent pressure ulcers arising in the sacrum and coccyx of patients with persistent severe diarrhea and/or... (Randomized Controlled Trial)
Randomized Controlled Trial
To determine whether multilayer silicone foam dressings can prevent pressure ulcers arising in the sacrum and coccyx of patients with persistent severe diarrhea and/or fragile skin. This randomized, 14-day controlled trial included 600 hospitalized patients with persistent severe diarrhea and/or fragile skin who were at high risk of developing pressure ulcers. All participants were enrolled from three Japanese institutions. Participants meeting all inclusion and exclusion criteria were randomized using the Excel program to receive standard care (control; = 300) recommended by Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx (intervention; = 300). Significantly more participants in the control than the intervention group developed pressure ulcers (22 vs. 5, = 0.001). The incidence of pressure ulcers remains high in hospitalized patients at high risk of developing pressure ulcers. The present findings might contribute to novel preventive strategies for patients at high risk of developing pressure ulcers. Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.
Topics: Aged; Aged, 80 and over; Bandages; Critical Care; Female; Heel; Humans; Japan; Male; Middle Aged; Pressure Ulcer; Sacrum; Silicones
PubMed: 33124968
DOI: 10.1089/wound.2019.1002 -
The British Journal of Dermatology Jul 2021Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). (Randomized Controlled Trial)
Randomized Controlled Trial
Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial.
BACKGROUND
Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs).
OBJECTIVES
To determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone.
METHODS
This was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites.
RESULTS
In the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41-0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35-0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34-1·68, P = 0·49).
CONCLUSIONS
Silicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas.
Topics: Adhesives; Adult; Bandages; Hospitals; Humans; Pressure Ulcer; Silicones
PubMed: 33216969
DOI: 10.1111/bjd.19689 -
International Journal of Cosmetic... Oct 2022Nowadays, the use of silicones in cosmetic formulation is still controversial, given that "natural" or "biodegradable" components are preferred. Often, the exclusion...
OBJECTIVE
Nowadays, the use of silicones in cosmetic formulation is still controversial, given that "natural" or "biodegradable" components are preferred. Often, the exclusion and/or the discrimination of these excipients from cosmetic field are unmotivated because all things cannot be painted with the same brush. Hence, we want to bring to light and underline the advantages of including silicones in cosmetic emulsions, refuting and debunking some myths related to their use.
METHODS
Silicone-free and silicone-based emulsions were obtained within an easy homogenization process. Droplet size distribution was assessed by laser diffraction particle size analyser Mastersizer 2000™, and by optical microscopy. The long-time stability profiles were investigated thanks to the optical analyser Turbiscan® Lab Expert. Diffusing wave spectroscopy (DWS) by Rheolaser Master™ and frequency sweep measurements by Kinexus® Pro Rotational Rheometer were carried out to assess a full rheological characterization. In vivo studies were carried out by the evaluation of Trans Epidermal Water Loss (TEWL) over time on healthy human volunteers. A skin feeling rating was collected from the same volunteers by questionnaire.
RESULTS
From size distribution analysis, a better coherence of data appeared for silicone-based emulsion, as the size of the droplets was kept unchanged after 1 month, as well as the uniformity parameter. Morphological investigation confirmed a homogenous droplet distribution for both samples. Silicones enhanced the viscosity, compactness and strength of the cream, providing a suitable stability profile both at room temperature and when heated at 40°C. The solid-like viscoelastic behaviour was assessed in the presence of dynamic oscillatory stresses. The monitoring of TEWL over time demonstrated non-occlusive properties of emulsions containing silicones, the values of which were comparable to the negative control. Silicone-based emulsions gained higher scores from the volunteers in silkiness, freshness and softness features, while lower scores were obtained in greasiness compared to silicone-free emulsions. No cases of irritation were recorded by the candidates.
CONCLUSION
The presence of specific silicones inside a cosmetic product improved its technological characteristics. The rheological identity and the stability feature showed the real suitability of prepared emulsion as a cosmetic product. Moreover, this study demonstrated that silicone-based emulsions are safe for the skin and did not cause skin occlusion. Improved skin sensations are registered by potential consumers when silicones are included in the formulation.
Topics: Cosmetics; Emulsions; Humans; Rheology; Silicones; Skin; Water
PubMed: 35815903
DOI: 10.1111/ics.12800 -
Trials Jan 2023Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is still emerging. This trial aims to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral pressure injuries in medical-surgical patients.
METHODS
This is a multicentre, pragmatic, parallel group, randomised controlled trial. A sample size of 1320 was calculated to have >90% power to detect a 5% difference in the primary outcome at an alpha of 0.05. Adult patients admitted to participating medical-surgical wards are screened for eligibility: ≥18 years, admitted to hospital within the previous 36 h, expected length of stay of ≥24 h, and assessed high risk for hospital-acquired pressure injury. Consenting participants are randomly allocated to either prophylactic silicone foam dressing intervention or usual care without any dressing as the control group via a web-based randomisation service independent of the trial. Patients are enrolled across three Australian hospitals. The primary outcome is the cumulative incidence of patients who develop a sacral pressure injury. Secondary outcomes include the time to sacral pressure injury, incidence of severity (stage) of sacral pressure injury, cost-effectiveness of dressings, and process evaluation. Participant outcomes are assessed daily for up to 14 days by blinded independent outcome assessors using de-identified, digitally modified sacral photographs. Those who develop a sacral pressure injury are followed for an additional 14 days to estimate costs of pressure injury treatment. Analysis of clinical outcomes will be based on intention-to-treat, per-protocol, and sensitivity analyses.
DISCUSSION
This trial aims to provide definitive evidence on the effect prophylactic dressings have on the development of hospital-acquired sacral pressure injuries in medical-surgical patients. A parallel economic evaluation of pressure injury prevention and treatment will enable evidence-informed decisions and policy. The inclusion of a process evaluation will help to explain the contextual factors that may have a bearing on trial results including the acceptability of the dressings to patients and staff. The trial commenced 5 March 2020 and has been significantly delayed due to COVID-19.
TRIAL REGISTRATION
ANZCTR ACTRN12619000763145. Prospectively registered on 22 May 2019.
Topics: Adult; Humans; Pressure Ulcer; Australia; COVID-19; Bandages; Deafness; Silicones
PubMed: 36721259
DOI: 10.1186/s13063-022-06999-y -
Journal of Biomedical Optics Feb 2022Tissue-like solid phantoms with identical optical properties, known within tolerant uncertainty, are of crucial importance in diffuse optics for instrumentation...
SIGNIFICANCE
Tissue-like solid phantoms with identical optical properties, known within tolerant uncertainty, are of crucial importance in diffuse optics for instrumentation assessment, interlaboratory comparison studies, industrial standards, and multicentric clinical trials.
AIM
The reproducibility in fabrication of homogeneous solid phantoms is focused based on spectra measurements by instrument comparisons grounded on the time-resolved diffuse optics.
APPROACH
Epoxy-resin and silicone phantoms are considered as matrices and both employ three different instruments for time-resolved diffuse spectroscopy within the spectral range of 540 to 1100 nm. In particular, we fabricated two batches of five phantoms each in epoxy resin and silicone. Then, we evaluated the intra- and interbatch variability with respect to the instrument precision, by considering the coefficient of variation (CV) of absorption and reduced scattering coefficients.
RESULTS
We observed a similar precision for the three instruments, within 2% for repeated measurements on the same phantom. For epoxy-resin phantoms, the intra- and the interbatch variability reached the instrument precision limit, demonstrating a very good phantom reproducibility. For the silicone phantoms, we observed larger values for intra- and interbatch variability. In particular, at worst, for reduced scattering coefficient interbatch CV was about 5%.
CONCLUSIONS
Results suggest that the fabrication of solid phantoms, especially considering epoxy-resin matrix, is highly reproducible, even if they come from different batch fabrications and are measured using different instruments.
Topics: Optics and Photonics; Phantoms, Imaging; Reproducibility of Results; Silicones; Spectrum Analysis
PubMed: 35112513
DOI: 10.1117/1.JBO.27.7.074713 -
European Annals of Otorhinolaryngology,... Oct 2019
Topics: Biomechanical Phenomena; Breast Implants; Breast Neoplasms; Cochlear Implantation; Cochlear Implants; Female; Humans; Lymphoma, Large-Cell, Anaplastic; Prosthesis Design; Silicones
PubMed: 31006640
DOI: 10.1016/j.anorl.2019.04.015 -
Clinical & Experimental Optometry Apr 2022Contact lens prescribing data serve as a benchmark for eye care clinicians in assessing their own prescribing patterns and provide useful contextual information for...
CLINICAL RELEVANCE
Contact lens prescribing data serve as a benchmark for eye care clinicians in assessing their own prescribing patterns and provide useful contextual information for researchers and the contact lens industry.
PURPOSE
To document global trends in contact lens prescribing during the first two decades of this century.
METHODS
A longitudinal survey of contact lens prescribing was conducted by asking contact lens practitioners to provide 11 items of information from 10 consecutive contact lens fits between January and March each year from 1996 to 2020, inclusive.
RESULTS
Data relating to 406,859 contact lens fits were collected from 71 countries between 1996 and 2020, generating 4.5 million data points. Demographic analysis for 61 nations returning ≥100 fits demonstrated that a majority of lenses (65-70%) were fitted to females. The average age of lens wearers was 30.8 ± 13.9 years for males and 32.5 ± 14.3 years for females. Trend analysis of 20 countries returning prescribing data for ≥13 years between 2000 and 2020 revealed the following: increase in the age of lens wearers; dramatic rise in the extent of fitting silicone hydrogel and daily disposable lenses; increased fitting of soft toric and multifocal lenses; increasing proportion of rigid lens fits in specialist (non-spherical) designs; incomplete provision of near contact lens corrections for contact lens wearing presbyopes; ongoing low levels of extended wear fits; and almost exclusive use of multi-purpose care systems. Daily disposable lenses were used for both full-time and part-time wear, whereas rigid and soft reusable lenses were primarily worn full time.
CONCLUSIONS
The evolution of international contact lens fitting over the first two decades of this century is documented. The data presented here may assist all stakeholders in advancing contact lens clinical practice, informing contact lens research, and guiding contact lens manufacturers.
Topics: Adolescent; Adult; Contact Lenses; Contact Lenses, Hydrophilic; Female; Humans; Male; Optometry; Prescriptions; Silicones; Surveys and Questionnaires; Young Adult
PubMed: 35184672
DOI: 10.1080/08164622.2022.2033604 -
Farmacia Hospitalaria : Organo Oficial... 2024The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous... (Review)
Review
OBJECTIVE
The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
METHOD
A systematic review was performed following the PRISMA 2020 Guidelines by searching PubMed with the descriptors: "silicone" AND "syringes" AND ("intraocular" OR "intravitreal") and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
RESULTS
Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone, the administration technique, the physicochemical aspects of silicone release, and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialized syringes, the existing syringes for this use have been collected, finding two that will probably be commercialized in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
CONCLUSIONS
From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
Topics: Syringes; Humans; Silicone Oils; Intravitreal Injections; Off-Label Use; Spain
PubMed: 38556370
DOI: 10.1016/j.farma.2024.01.008