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The Journal of Craniofacial Surgery Jun 2024Congenital nasolacrimal duct obstruction (CNLDO) is a pediatric disorder with a wide range of pathology. If untreated, the condition may end up with serious... (Meta-Analysis)
Meta-Analysis Comparative Study
OBJECTIVE
Congenital nasolacrimal duct obstruction (CNLDO) is a pediatric disorder with a wide range of pathology. If untreated, the condition may end up with serious complications. Multiple treatment options for CNLDO exist throughout the literature, and there is an ongoing debate on the best intervention for each disease subgroup and the best timing of such interventions. This study compares the success and failure rates of silicone tube intubation (STI) against probing and balloon dilation (BD).
METHODS
The authors searched the literature for relevant articles using PubMed, Scopus, web of Science, and Cochrane Library until January 2024. Using RevMan 5.4, the authors compared STI's success and failure rates to probing and BD using risk ratios (RRs) and a random-effect model. In addition, the complication rate of monocanalicular intubation (MCI) versus bicanalicular intubation (BCI) was investigated. The authors used the leave-one-out method to check for influential studies and to resolve heterogeneity.
RESULTS
The screening process resulted in 23 eligible articles for inclusion in the authors' review. Silicone tube intubation had a higher chance of resolving the symptoms of CNLDO than probing (RR = 1.11; 95% CI: 1.04, 1.20; P = 0.004) while having less risk of surgical failure (RR = 0.48; 95% CI: 0.30, 0.76; P = 0.002]. Monocanalicular intubation showed no statistically significant difference when compared with BCI in terms of surgical success and failure; however, MCI had a lower risk of complications (RR = 0.68; 95% CI: 0.48, 0.97; P = 0.04). In addition, STI did not demonstrate any significant difference from BD.
CONCLUSION
There was no significant difference in success/failure between MCI and BCI; monocanalicular had fewer complications. Silicone tube intubation did better in terms of surgical success than probing, especially in children over 12 months, suggesting that it is the preferred intervention for older patients with CNLDO.
Topics: Humans; Infant; Dilatation; Intubation; Lacrimal Duct Obstruction; Nasolacrimal Duct; Silicones; Treatment Outcome; Child, Preschool
PubMed: 38727216
DOI: 10.1097/SCS.0000000000010273 -
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 commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised 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: 38705829
DOI: 10.1016/j.farma.2024.04.011 -
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 -
Journal of Plastic, Reconstructive &... Mar 2024Implant-based breast augmentations and reconstructions are one of the most common surgical procedures performed by plastic surgeons in the United States, which has... (Review)
Review
INTRODUCTION
Implant-based breast augmentations and reconstructions are one of the most common surgical procedures performed by plastic surgeons in the United States, which has rapidly increased in popularity since the 2000s. Silicone lymphadenopathy (SL) is a complication of breast implants that involves migration of silicone to nearby soft tissue/lymph nodes. Data on its clinical features and management is scarce.
METHODS
SL-related search terms were used to find articles in 3 databases. Of 598 articles, 101 studies met the inclusion criteria. Demographics, clinical presentation, workup, and management data were analyzed.
RESULTS
Of 279 cases of SL and 107 with information on initial diagnosis, 35 (33%) were incidental. The most common symptom was painless lymphadenopathy, followed by painful lymphadenopathy. 251 (95%) and 13 (5%) patients had silicone and saline implants, respectively. 149 (68%) patients had implant rupture. Axillary lymphadenopathy was the most affected region (136 cases, 72%), followed by internal mammary (40 cases, 21%), cervical/supraclavicular (36 cases, 19%), and mediastinal (24 cases, 13%) regions. 25% of patients underwent fine-needle aspiration, 12% core needle biopsy, and 59% excisional biopsy. 32% of cases underwent explantation and/or implant exchange. The most common indication for surgery was implant rupture. Histology showed multinucleated giant cells, large histiocytes, and silicone accumulation.
CONCLUSIONS
SL is a complication associated with breast implants. The majority of patients are asymptomatic, and most cases are managed conservatively. Minority need a biopsy and surgical interventions due to abnormal imaging, persistent symptoms, and/or implant rupture. Workup and management should be tailored to the patient.
Topics: Humans; Silicone Gels; Prevalence; Lymphadenopathy; Breast Implants; Breast Implantation
PubMed: 38364672
DOI: 10.1016/j.bjps.2024.01.011 -
Foot and Ankle Surgery : Official... Apr 2024Hallux rigidus is the most frequent arthritis of the foot, due to multiple factors. Arthrodesis and interposition arthroplasty are treatments considered in advanced... (Review)
Review
UNLABELLED
Hallux rigidus is the most frequent arthritis of the foot, due to multiple factors. Arthrodesis and interposition arthroplasty are treatments considered in advanced stages of the disease, when conservative treatment has failed. Although arthrodesis may be considered the technique recommended by multiple authors, for patients in whom joint mobility is to be preserved, arthroplasty could represent a reliable alternative. The purpose of this systematic review is to investigate and compare the clinical outcomes and complications of arthrodesis and interposition arthroplasty for moderate and severe stages of hallux rigidus.
METHODS
For this systematic review we searched COCHRANE, EMBASE, PUBMED databases. Twenty-six research papers were obtained, with a total of 1348 feet, which were included for qualitative analysis. The following groups were included: Cartiva hemiarthroplasty (286), double stem silicone arthroplasty (276), total metallic arthroplasty (394) and arthrodesis (392).
RESULTS
In the arthrodesis group, the AOFAS-HMI score was the most used, ranging from 36 to 45 in the preoperative period and from 79 to 89 in the postoperative period. The greatest improvement in the VAS PAIN score was from 86 to 4. The fusion rate was 98.6% of the total number of cases, the most frequent complication was pain due to material discomfort. In the total metallic arthroplasty group, the ROTO-GLIDE system reported an AOFAS score of 95 points, with low complication rates; but, with the TOEFIT-PLUS and BIOMED-MERCK systems, despite the good postoperative value, they report 37% and 15% revision due to aseptic loosening in the series with the longest follow-up, respectively. The Cartiva group showed a significative increase in FAAM ADL and FAAM SPORT from 59.4 to 90.4 and from 60.9 to 89.7, respectively; similarly, 20.5% implant removal and conversion to arthrodesis were reported. Finally, the double stem silicone arthroplasty group, in the series with the longest follow-up, it manages to improve the MOXFQ score from 78.1 to 11.0, with an average range of mobility of 22.3 degrees. Lysis was reported in 10% of cases.
CONCLUSIONS
Arthrodesis has proven to be the best option for the treatment of advanced hallux rigidus. Arthroplasty can be a valid option for patients who demand to maintain the range of mobility of the joint; however, it is important to inform about the complications that may arise in the short and medium term.
LEVEL OF CLINICAL EVIDENCE
II.
Topics: Humans; Hallux Rigidus; Metatarsophalangeal Joint; Arthroplasty; Hemiarthroplasty; Arthrodesis; Silicones; Treatment Outcome; Follow-Up Studies; Retrospective Studies
PubMed: 38262785
DOI: 10.1016/j.fas.2023.12.002 -
BMC Oral Health Jan 2024The effectiveness of newly developed elastomeric polymer hybrid siloxane (PVES), which combines the properties of polyethylene (PE) and polyvinyl siloxane (PVS)... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The effectiveness of newly developed elastomeric polymer hybrid siloxane (PVES), which combines the properties of polyethylene (PE) and polyvinyl siloxane (PVS) elastomers, has been a subject of interest in recent studies. This study aimed to assess the physical properties of hybrid PVES materials by analyzing existing data from recent studies on this topic.
METHODS
A systematic literature search was conducted to retrieve peer-reviewed articles published up to February 5, 2023. The population, intervention, comparison, and pertinent outcomes were specified under the PICO framework. The primary data analysis was performed in Microsoft Excel, while statistical analysis used Meta-Essentials.
RESULTS
Of the 1152 articles assessed, 14 met the inclusion criteria. The meta-analysis of the selected studies indicated that polyether (PE) and polyvinyl siloxane (PVS) were highly correlated (two-tailed p-values of 0.000 and 0.001, respectively) with the improved tensile strength of vinyl polyether siloxane (PVES) with a significantly positive effect size. Similarly, the hydrophilic characteristics of PVES were significantly improved compared to those of PE and PVS. PE was a significant contributor to the hydrophilic characteristics of PVES, with a two-tailed p-value of 0.000. The effect size was highly positive for hydrophilicity but showed high heterogeneity. It was also observed that the dimensional accuracy of PVES was comparable to those of PE and PVS, with no statistically significant differences among the three materials.
CONCLUSIONS
PVES showed promising features, with improved tensile strength and hydrophilic characteristics compared to those of PE and PVS.
Topics: Humans; Siloxanes; Polyethylene; Elastomers; Parents
PubMed: 38195442
DOI: 10.1186/s12903-023-03830-1 -
The Cochrane Database of Systematic... Jan 2024Burn damage to skin often results in scarring; however in some individuals the failure of normal wound-healing processes results in excessive scar tissue formation,... (Review)
Review
BACKGROUND
Burn damage to skin often results in scarring; however in some individuals the failure of normal wound-healing processes results in excessive scar tissue formation, termed 'hypertrophic scarring'. The most commonly used method for the prevention and treatment of hypertrophic scarring is pressure-garment therapy (PGT). PGT is considered standard care globally; however, there is continued uncertainty around its effectiveness.
OBJECTIVES
To evaluate the benefits and harms of pressure-garment therapy for the prevention of hypertrophic scarring after burn injury.
SEARCH METHODS
We used standard, extensive Cochrane search methods. We searched CENTRAL, MEDLINE, Embase, two other databases, and two trials registers on 8 June 2023 with reference checking, citation searching, and contact with study authors to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing PGT (alone or in combination with other scar-management therapies) with scar management therapies not including PGT, or comparing different PGT pressures or different types of PGT.
DATA COLLECTION AND ANALYSIS
At least two review authors independently selected trials for inclusion using predetermined inclusion criteria, extracted data, and assessed risk of bias using the Cochrane RoB 1 tool. We assessed the certainty of evidence using GRADE.
MAIN RESULTS
We included 15 studies in this review (1179 participants), 14 of which (1057 participants) presented useable data. The sample size of included studies ranged from 17 to 159 participants. Most studies included both adults and children. Eight studies compared a pressure garment (with or without another scar management therapy) with scar management therapy alone, five studies compared the same pressure garment at a higher pressure versus a lower pressure, and two studies compared two different types of pressure garments. Studies used a variety of pressure garments (e.g. in-house manufactured or a commercial brand). Types of scar management therapies included were lanolin massage, topical silicone gel, silicone sheet/dressing, and heparin sodium ointment. Meta-analysis was not possible as there was significant clinical and methodological heterogeneity between studies. Main outcome measures were scar improvement assessed using the Vancouver Scar Scale (VSS) or the Patient and Observer Scar Assessment Scale (POSAS) (or both), pain, pruritus, quality of life, adverse events, and adherence to therapy. Studies additionally reported a further 14 outcomes, mostly individual scar parameters, some of which contributed to global scores on the VSS or POSAS. The amount of evidence for each individual outcome was limited. Most studies had a short follow-up, which may have affected results as the full effect of any therapy on scar healing may not be seen until around 18 months. PGT versus no treatment/lanolin We included five studies (378 participants). The evidence is very uncertain on whether PGT improves scars as assessed by the VSS compared with no treatment/lanolin. The evidence is also very uncertain for pain, pruritus, adverse events, and adherence. No study used the POSAS or assessed quality of life. One additional study (122 participants) did not report useable data. PGT versus silicone We included three studies (359 participants). The evidence is very uncertain on the effect of PGT compared with silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, adherence, and other scar parameters. It is possible that silicone may result in fewer adverse events or better adherence compared with PGT but this was also based on very low-certainty evidence. PGT plus silicone versus no treatment/lanolin We included two studies (200 participants). The evidence is very uncertain on whether PGT plus silicone improves scars as assessed by the VSS compared with no treatment/lanolin. The evidence is also very uncertain for pain, pruritus, and adverse events. No study used the POSAS or assessed quality of life or adherence. PGT plus silicone versus silicone We included three studies (359 participants). The evidence is very uncertain on the effect of PGT plus silicone compared with silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, and adherence. PGT plus scar management therapy including silicone versus scar management therapy including silicone We included one study (88 participants). The evidence is very uncertain on the effect of PGT plus scar management therapy including silicone versus scar management therapy including silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, and adherence. High-pressure versus low-pressure garments We included five studies (262 participants). The evidence is very uncertain on the effect of high pressure versus low pressure PGT on adverse events and adherence. No study used the VSS or the POSAS or assessed pain, pruritus, or quality of life. Different types of PGT (Caroskin Tricot + an adhesive silicone gel sheet versus Gecko Nanoplast (silicone gel bandage)) We included one study (60 participants). The evidence is very uncertain on the effect of Caroskin Tricot versus Gecko Nanoplast on the POSAS, pain, pruritus, and adverse events. The study did not use the VSS or assess quality of life or adherence. Different types of pressure garments (Jobst versus Tubigrip) We included one study (110 participants). The evidence is very uncertain on the adherence to either Jobst or Tubigrip. This study did not report any other outcomes.
AUTHORS' CONCLUSIONS
There is insufficient evidence to recommend using either PGT or an alternative for preventing hypertrophic scarring after burn injury. PGT is already commonly used in practice and it is possible that continuing to do so may provide some benefit to some people. However, until more evidence becomes available, it may be appropriate to allow patient preference to guide therapy.
Topics: Adult; Child; Humans; Cicatrix; Lanolin; Silicone Gels; Burns; Pain; Pruritus
PubMed: 38189494
DOI: 10.1002/14651858.CD013530.pub2 -
Journal of Physiotherapy Jan 2024In adults with a burn injury, do non-invasive therapies improve pain and burn scar pruritus, elasticity and vascularisation? Are any effects maintained beyond the...
QUESTIONS
In adults with a burn injury, do non-invasive therapies improve pain and burn scar pruritus, elasticity and vascularisation? Are any effects maintained beyond the intervention period?
DESIGN
Systematic review of randomised trials with meta-analyses.
PARTICIPANTS
Adults with burn scars.
INTERVENTION
The experimental intervention was a non-invasive (ie, non-surgical or non-pharmacological) therapy applied to the burn scar.
OUTCOME MEASURES
Pain intensity, pruritus intensity, elasticity and vascularisation.
RESULTS
Fifteen trials involving 780 participants were included. The results indicated a beneficial effect on pain intensity on a 0-to-10 scale after massage (MD -1.5, 95% CI -1.8 to -1.1), shockwave therapy (MD -0.8, 95% CI -1.2 to -0.4) and laser (MD -4.0, 95% CI -6.0 to -2.0). The results indicated a beneficial effect on pruritus intensity on a 0-to-10 scale after massage (MD -0.4, 95% CI -0.7 to -0.2), shockwave therapy (MD -1.3, 95% CI -2.3 to -0.3) and laser (MD -4.8, 95% CI -6.1 to -3.5). Massage, shockwave therapy and silicone produced negligible or unclear benefits on scar elasticity and vascularisation. The quality of evidence varied from low to moderate.
CONCLUSION
Among all commonly used non-invasive therapies for the treatment of burn scars, low-to-moderate quality evidence indicated that massage, laser and shockwave therapy reduce pain and the intensity of scar pruritus. Low-to-moderate quality evidence suggested that massage, shockwave therapy and silicone have negligible or unclear effects for improving scar elasticity and vascularisation.
REVIEW REGISTRATION
PROSPERO (CRD42021258336).
Topics: Adult; Humans; Cicatrix, Hypertrophic; High-Energy Shock Waves; Pruritus; Pain; Lasers; Burns; Massage; Silicones
PubMed: 38072714
DOI: 10.1016/j.jphys.2023.10.010 -
Dermatology Online Journal Aug 2023Although postoperative scarring may be considered a cosmetic concern, it can greatly impact a patient's quality of life. This extends beyond psychosocial burden...
Although postoperative scarring may be considered a cosmetic concern, it can greatly impact a patient's quality of life. This extends beyond psychosocial burden influenced by hypertrophic scars and keloids, as patients also experience discomfort and pain. This systematic review evaluates the efficacy of silicone gel (SG)-based products in preventing postoperative abnormal scar formation. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a PubMed search was performed to find randomized, controlled trials investigating the effect of SG-based products on postoperative wound healing. The search yielded 359 publications, but only 30 studies published between 1991-2022 were found to fit the inclusion criteria. Outcomes were extracted from the literature and subsequent quality and risk of bias assessments were performed. Most studies indicated improvement of at least one quality of the scar with the use of SG-based products. The greatest potential variable increasing bias was an inadequate control group. Studies also suffered from small sample sizes, use of unvalidated scar assessment scales, lack of double-blinding, and short follow-up periods. Overall, SG-based products demonstrated potential in preventing abnormal scar formation during postoperative healing, but further studies are required to validate the results of current literature.
Topics: Humans; Silicone Gels; Quality of Life; Randomized Controlled Trials as Topic; Cicatrix, Hypertrophic; Keloid
PubMed: 37921811
DOI: 10.5070/D329461860 -
The Laryngoscope May 2024Unilateral vocal fold paralysis or paresis (UVFP) is a condition that causes significant morbidity due to dysphonia, dysphagia, and aspiration. Type I medialization... (Review)
Review
INTRODUCTION
Unilateral vocal fold paralysis or paresis (UVFP) is a condition that causes significant morbidity due to dysphonia, dysphagia, and aspiration. Type I medialization thyroplasty (MT) is the current mainstay surgical treatment for UVFP. Though widely considered a safe procedure, concerns exist over possible airway complications which can lead to overnight observation. Herein, we report a systematic review of the safety and adverse events of MT to aid in determining the safety of same-day discharge.
DATA SOURCES
PubMed and Embase databases.
REVIEW METHODS
Our search identified studies investigating complications associated with MT. Articles were selected if published between January 1, 1989 and March 15, 2023. Abstracts were screened, and data were extracted from included studies. Only Type I MT procedures were included; case reports were excluded. Participant characteristics, intervention details, results, and adverse events were extracted.
RESULTS
The database query identified 751 abstracts, of which 46 studies met eligibility criteria. A total of 2426 patients underwent MT. The most common implant was Silastic (n = 898, 37.0%) followed by Gore-Tex (n = 664, 27.4%). There were 254 (10.5%) total complications reported; 110 (4.5%) were considered major. The most common complication was nonobstructive hematoma (n = 59, 2.4%) followed by hemorrhage (n = 36, 1.5%). Implant extrusion (n = 24, 0.99%) or displacement (n = 15, 0.62%) occurred mostly in Silastic and Gore-Tex implants. Same-day discharge occurred with 429 patients and was not associated with adverse events.
CONCLUSIONS
UVFP can be reliably improved by MT with a low risk of complications. Outpatient MT is a promising treatment with a favorable safety profile. Laryngoscope, 134:1994-2004, 2024.
Topics: Humans; Laryngoplasty; Dimethylpolysiloxanes; Vocal Cord Paralysis; Polytetrafluoroethylene; Treatment Outcome
PubMed: 37916789
DOI: 10.1002/lary.31141