[A randomized controlled trial on the effect of early eschar dermabrasion combined with antimicrobial soft silicone foam dressing in the treatment of deep partial-thickness burn wounds in children].

Objective: To explore the effect of early eschar dermabrasion combined with antimicrobial soft silicone foam dressing (hereinafter referred to as foam dressing) in treating the deep partial-thickness burn wounds in children. Methods: This study was a randomized controlled trial. From June 2021 to December 2022, 78 pediatric patients with deep partial-thickness burns who met the inclusion criteria were admitted to the Department of Burns in Guiyang Steel Plant Employees Hospital. According to the random number table, the pediatric patients were divided into two groups, with 38 cases left in combined treatment group (with 20 males and 18 females, aged 26.00 (16.75, 39.75) months) and 39 cases in foam dressing group (with 21 males and 18 females, aged 19.00 (14.00, 31.00) months) after the exclusion of one dropped-out child in follow-up. The pediatric patients in combined treatment group underwent eschar dermabrasion of the wound within 48 hours after injury, the wound was covered with foam dressing after operation, and the dressing was replaced once every 7 days; for the pediatric patients in foam dressing group, the wound was sterilized within 48 hours after injury and covered with foam dressing, and the dressing was replaced once every 2 to 3 days. After the wound healing, the children in both groups were routinely applied with silicone gel twice a day for 3 weeks before started wearing elastic sleeves for more than 18 hours a day, and continuously for over than 6 months. The degree of pain during dressing change was evaluated using the children's pain behavior inventory FLACC. The adverse reactions during the treatment period, number of dressing changes, and wound healing time were observed and recorded. Six months after wound healing, the Vancouver scar scale (VSS) was used to evaluate the condition of the wound scar. Results: When changing dressing, the FLACC score for pain of pediatric patients in combined treatment group was 3.5 (2.0, 5.0), which was significantly lower than 6.0 (5.0, 8.0) in foam dressing group (Z=-5.40, P<0.05). During the treatment period, no adverse reactions such as wound edema, fluid accumulation, or peripheral skin rash allergies occurred in any pediatric patient in both groups. The number of dressing changes of pediatric patients in combined treatment group was 3 (3, 4) times, which was significantly less than 8 (7, 10) times in foam dressing group (Z=-7.58, P<0.05). The wound healing time of pediatric patients in combined treatment group was (19±5) days, which was significantly shorter than (25±6) days in foam dressing group (t=-4.48, P<0.05). Six months after wound healing, the VSS score for scar of pediatric patients in combined treatment group was 5 (2, 8), which was significantly lower than 7 (5, 10) in foam dressing group (Z=-3.05, P<0.05). Conclusions: Compared with using foam dressings alone, early eschar dermabrasion combined with foam dressings can reduce the number of dressing changes, alleviate the pain during dressing changes, and shorten the wound healing time in treating children with deep partial-thickness burns, and effectively alleviate scar hyperplasia by combining with anti-scar treatment post burns.

Microvascular changes on optical coherence tomography angiography after rhegmatogenous retinal detachment vitrectomy with silicone tamponade.

PURPOSE: We aimed to evaluate microvascular changes on optical coherence tomography angiography (OCTA) in patients with rhegmatogenous retinal detachment (RRD) who underwent silicone oil (SO) tamponade and compare changes according to macular involvement. METHODS: This retrospective study included 48 patients with unilateral RRD who underwent vitrectomy and SO tamponade and were stable after SO removal. Control data were obtained from the fellow healthy eye. Ophthalmic examinations, including best corrective visual acuity (BCVA) and OCTA, were conducted. Differences in vascular density (VD) in different sections of the macula and differences in the foveal avascular zone (FAZ) were analyzed between the affected eyes and control eyes. Subgroup analyses according to macular involvement were performed. RESULTS: Baseline BCVA and duration of SO tamponade were associated with postoperative BCVA (p<0.001, p = 0.03, respectively). The average VD in the deep capillary plexus (DCP) and the VD of the nasal parafoveal area in both the superficial capillary plexus (SCP) and the DCP decreased relative to those in the control eyes (p = 0.026, p = 0.028, and p = 0.031, respectively). The FAZ area in the DCP and in the SCP also increased when compared with that in the controls (p = 0.043, p = 0.002, respectively). In addition, the macular-off RRD group had lower VD in the nasal parafoveal area of the DCP than the macular-on RRD group. CONCLUSION: SO tamponade could cause microvascular changes, especially in the nasal parafoveal area. The macular-off RRD group were affected more than the macular-on RRD group.

Wound Healing Treatments After Ablative Laser Skin Resurfacing: A Review.

Laser resurfacing has progressed since the 1980s to treat a variety of medical and aesthetic indications with ever-evolving safety parameters. While laser technology has evolved to provide a more favorable safety profile and decrease wound healing time, advances in post-procedure healing agents have also helped to mitigate adverse effects, such as persistent erythema, dyspigmentation, acneiform eruptions, dermatitis, infections, and scarring. We reviewed the evidence of growth factors, stem cells, silicone and silicone polymers, botanical based treatments, fatty acids, probiotics, and closed dressings on post-ablative laser skin resurfacing. All reviewed agents demonstrated some evidence in improving post-procedure outcomes, albeit mixed in many cases. Additionally, these studies contain small numbers of participants, vary in type, strength, and clinical indication for which the resurfacing laser was used, and have differing postprocedural evaluation protocols and assessments. This highlights a need for standardization of clinical studies and the importance of choosing an optimal postprocedural skincare plan depending on every unique clinical scenario. J Drugs Dermatol. 2020;19(11):1050-1055. doi:10.36849/JDD.2020.5386.

Ex-vivo mechanical sealing properties and toxicity of a bioadhesive patch as sealing system for fetal membrane iatrogenic defects.

Preterm prelabor rupture of membranes (PPROM) is the most frequent complication of fetal surgery. Strategies to seal the membrane defect created by fetoscopy aiming to reduce the occurrence of PPROM have been attempted with little success. The objective of this study was to evaluate the ex-vivo mechanical sealing properties and toxicity of four different bioadhesives integrated in semi-rigid patches for fetal membranes. We performed and ex-vivo study using term human fetal membranes to compare the four integrated patches composed of silicone or silicone-polyurethane combined with dopaminated-hyaluronic acid or hydroxypropyl methylcellulose (HPMC). For mechanical sealing properties, membranes were mounted in a multiaxial inflation device with saline, perforated and sealed with the 4 combinations. We measured bursting pressure and maximum pressure free of leakage (n = 8). For toxicity, an organ culture of membranes sealed with the patches was used to measure pyknotic index (PI) and lactate dehydrogenase (LDH) concentration (n = 5). All bioadhesives achieved appropriate bursting pressures, but only HPMC forms achieved high maximum pressures free of leakage. Concerning toxicity, bioadhesives showed low PI and LDH levels, suggesting no cell toxicity. We conclude that a semi-rigid patch coated with HPMC achieved ex-vivo sealing of iatrogenic defects in fetal membranes with no signs of cell toxicity. These results warrant further research addressing long-term adhesiveness and feasibility as a sealing system for fetoscopy.

Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults.

BACKGROUND: Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled, multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D. METHODS/DESIGN: We will recruit 430 participants with IBS-D from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers and gut-related measurements from magnetic resonance imaging data. DISCUSSION: This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions. TRIAL REGISTRATION: ISRCTN17149988. Prospectively registered on 14 November 2017.

Efficacy of a silicone plug for patulous eustachian tube: A prospective, multicenter case series.

OBJECTIVES/HYPOTHESIS: To report the efficacy and safety of transtympanic plugging of the eustachian tube (ET) using a silicone plug (Kobayashi plug) for chronic patulous ET (PET). STUDY DESIGN: Prospective and multicenter trial conducted in which 30 PET patients were resistant to at least 6 months of conservative treatment. METHODS: The efficacy and safety of 28 and 27 patients, respectively, were analyzed. All patients fulfilled inclusion and exclusion criteria. The primary end point used the patulous eustachian tube handicap inventory-10 (PHI-10), and the secondary end point used ET function tests such as sonotubometry, tubo-tympano-aerodynamic-graphy, and respiratory movement of the tympanic membrane and auscultation of voice sounds transmitted from the nose through the ET to the external auditory canal at 3months after surgery. RESULTS: PHI-10 scores were 34.4 ± 4.2, 6.4 ± 9, and 5.7 ± 8.6 at screening, and 3 and 6 months after surgery. Twenty-three cases (82.1%, 95% confidence interval: 63.1%-93.9%) were judged as successes. There were five cases (17.2%) of middle ear effusion, four cases (13.8%) of tympanic membrane perforation, and one case of tinnitus due to surgery to remove the plug. No severe or life-threatening complications were found. CONCLUSIONS: This study revealed the efficacy and safety of silicone plug insertion for severe PET patients. LEVEL OF EVIDENCE: 2 Laryngoscope, 130:1304-1309, 2020.

Vulvar Silicone Granuloma.

We report a case of vulvar silicone granulomas following injection of liquid silicone into the labia. The patient is a 51-yr-old female who presented with vulvar pain and enlarged, indurated labia majora. In the past, she had undergone bilateral labial cosmetic augmentation with a silicone-based filler injected directly into the labia and into the gluteal regions. This had been performed in a nonmedical setting. At surgery, oblong firm soft tissue masses were removed from both labia. Microscopically, the lesions demonstrated replacement of the subcutaneous adipose tissue by fibrous tissue containing innumerable round empty spaces of different sizes, either within or surrounded by macrophages and occasional foreign-body giant histiocytes. The clear vacuoles corresponded to silicone fluid which had been dissolved during tissue processing. There are only rare case reports of vulvar silicone granuloma in the literature, and these were due to migration of silicone to the vulva from distant sites. Our report details a case of vulvar silicone granuloma secondary to direct injection of liquid silicone material into the labia.

Surgical excision combined with fully ablative carbon dioxide laser therapy and triamcinolone injections as a potential treatment for keloids in children.

BACKGROUND/OBJECTIVE: Keloids represent a functional and esthetic burden and can be particularly challenging to treat. Various topical, injectable, and ablative therapies exist but are associated with significant recurrence if used alone. We wanted to evaluate the long-term efficacy of multimodal therapy in pediatric patients treated for keloids at the Sainte-Justine University Hospital Center. METHODS: We conducted a retrospective case study of 21 children with 21 keloids treated between April 2006 and April 2016. The following combination of treatments was studied: surgical excision, carbon dioxide (CO2 ) laser therapy on the surgical site, and triamcinolone acetonide (TAC) intralesional injections during surgery and follow-up. Depending on the site treated, pressure garments and/or topical silicone were also used. RESULTS: Of the 21 patients initially treated, four were lost to follow-up. Of the 17 patients who had adequate follow-up (mean duration 18 months, with periodic reassessments and additional TAC injections if needed), 6 (35%) had some recurrence, with remission in three of them following subsequent treatment and three lost to follow-up. In summary, 14 (82.4%) of the patients with adequate follow-up had complete clearance of the keloid. However, this must be interpreted in light of the fact there was a significant loss of follow-up (33.3%) from the initial cohort. CONCLUSION: Our results are in agreement with other recent studies that demonstrate the need for multimodal therapy with combined methods in order to achieve long-term remission. A randomized controlled trial would be necessary to assess the real benefit of this treatment combination in children.

Silicone perforated punctal plugs for the treatment of punctal stenosis / Tampões perfurados de silicone no tratamento da estenose do ponto lacrimal

ABSTRACT Purpose: Punctal stenosis can result in symptoms such as epiphora and can significantly reduce the quality of life of patients. Perforated punctal plug insertion is an easy procedure that is commonly used as the first step of treatment for punctal stenosis. Methods: Clinical, demographic, and outcome data were retrospectively collected for 54 eyes of 21 males and 11 females who consecutively presented to our Oculoplastic Clinic and underwent silicone Micro Flow perforated punctal plug insertion. All patients had epiphora with punctal stenosis. Results: Of the 54 plugs, 26 plugs (48.1%) were lost and 28 (51.8%) stayed in place. Of the latter, eight were explanted because of the occlusion of the plug with secretions and recurrent conjunctivitis; moreover, two plugs migrated deep into the vertical canaliculus. Of the 54 plugs, only 18 (33.3%) were well-tolerated with significant symptomatic improvement. Conclusion: Plug loss is a prominent problem in patients implanted with perforated punctal plugs. Silicone punctal plugs failed in 66.7% of our patients over a mean follow-up of 14.2 months.

RESUMO Objetivo: A estenose punctal pode resultar em sintomas como a epífora e diminuir significativamente a qua­lidade de vida dos pacientes. A inserção de um tampão perfurado é um procedimento fácil que é comumente usado como o primeiro passo do tratamento para a estenose punctal. Métodos: Dados clínicos, demográficos e de resultado foram coletados retrospectivamente de 54 olhos de 21 homens e 11 mulheres que consecutivamente se apresentaram em nossa Clínica de Oculoplástica e foram submetidos a inserção de um tampão de silicone perfurado Micro Flow. Todos os pacientes tinham epífora com estenose punctal. Resultados: Dos 54 tampões, 26 (48,1%) foram perdidos e 28 (51,8%) permaneceram no local. Destes últimos, 8 foram removidos devido a oclusão do tampão com secreção e conjuntivite recorrente, além disso, 2 migraram profundamente no canalículo vertical. Dos 54 tampões, apenas 18 (33,3%) foram bem tolerados com significativa melhora dos sintomas. Conclusão: A perda de tampões é um problema de destaque em pacientes implantados com tampões perfurados. Tampões de silicone falharam em 66,7% dos pacientes durante um seguimento médio de 14,2 meses.

[Acute Respiratory Failure after Silicone Injection]. / Akutes respiratorisches Versagen durch Silikon-Injektion.

A 35-year-old male patient presented to the emergency department with complains of fever, dyspnea and petechiae. The chest X-ray revealed signs of bipulmonary infiltration. 5 days ago, an illicit silicone injection was performed into the penis for cosmetic reasons. Due to progressive respiratory failure the patient required mechanical ventilation. Bronchoalveolar lavage revealed diffuse alveolar hemorrhage. Silicone pneumonitis with a severe acute respiratory failure based on silicone embolization syndrome was diagnosed. Prone positioning, lung-protective ventilation and corticosteroid therapy were initiated. The patient was discharged from ICU after 19 days. In an outpatient follow up, lung function was fully recovered. CONCLUSION: Silicone pneumonitis should be considered in case of fever, respiratory distress and alveolar hemorrhage linked to cosmetic procedures. High dose corticosteroid therapy and lung-protective ventilation strategies may help for complete recovery of lung function.

Clinical and Antimicrobial Efficacy of a Silver Foam Dressing With Silicone Adhesive in Diabetic Foot Ulcers With Mild Infection.

The use of an antimicrobial dressing instead of a non-antimicrobial dressing may increase the number of diabetic foot ulcers healed over a medium-term follow-up period. The study aim was to evaluate the clinical and microbiological efficacy of a silver foam dressing in the management of diabetic foot ulcers. We conducted a single-center, prospective, open, noncontrolled study involving 21 outpatients with diabetic foot ulcers with mild infection. All patients received standard of care for their wounds and a silver foam dressing with silicone adhesive was applied twice per week for wound management during a 6-week treatment period. Soft tissue punch biopsies were taken every second week for qualitative and quantitative microbiological analysis. Wounds were assessed at patient admission, and wound bed tissue was evaluated for presence, quality, and consistency of granulation tissue. Clinical evaluation revealed improvements in wound conditions as a result of treatment with the silver dressing. Wollina wound scores improved significantly, from a mean score of 3.9 ± 1.6 points at inclusion to 6.1 ± 1.3 points at the end of the study (n = 19, P < .001). Treatment with the silver dressing resulted in significant decreases in the bioburden of classically considered diabetic foot ulcer pathogenic organisms such as Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus, Enterobacteriaceae species, Pseudomonas aeruginosa, and other nonfermenting gram-negative bacilli. Findings revealed that the use of silver foam dressing significantly reduced the pathogenic bacterial load and markedly improved the clinical outcome in patients with diabetic foot ulcer with mild infection over a 6-week treatment period.

A single-blind, randomised controlled trial of StrataXRT® - A silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patients with head and neck cancer.

AIM: Investigate the effects of StrataXRT® versus 10% Glycerine (Sorbolene cream) for preventing and managing radiation dermatitis in patients with head and neck cancer receiving radical radiotherapy (≥50 Gy) with or without chemotherapy or biotherapy. METHODS: A single-blind, randomised controlled, superiority trial was conducted. Patients either received StrataXRT® or Sorbolene (usual care). Skin toxicity, pain, itching and skin-related quality of life scores were collected from baseline, and up to four weeks post-treatment. RESULTS: A total of 197 patients were randomised into the study. Skin toxicity was dependent on the treatment group with StrataXRT® patients experiencing lower mean skin toxicity at the end of the radiation treatment (P = 0.002). At the end of treatment, the StrataXRT® arm had a lower percentage of grade 2 (80%) and grade 3 (28%) skin toxicity compared to the sorbolene arm (91% and 45% respectively). After adjustment for Cetuximab, the StrataXRT® arm had a 12% lower risk of experiencing grade 2 skin toxicity (RRR = 0.876, 95% CI: 0.778-0.987, P = 0.031); and a 36% lower risk of experiencing grade 3 skin toxicity (RRR = 0.648, 95% CI: 0.442-0.947, P = 0.025). Cox regression analysis showed that patients receiving StrataXRT® had a 41.0% and 49.4% reduced risks of developing grade 2 and 3 skin toxicity respectively throughout treatment compared to the Sorbolene arm. There were no differences between groups in patient-reported outcomes. No treatment interruptions and study product related adverse events were reported in either arm. CONCLUSION: StrataXRT® is effective for preventing, and delaying the development of grade 2 and 3 skin toxicity. TRIAL REGISTRATION: ACTRN12616000511437.

Silicone perforated punctal plugs for the treatment of punctal stenosis.

PURPOSE: Punctal stenosis can result in symptoms such as epiphora and can significantly reduce the quality of life of patients. Perforated punctal plug insertion is an easy procedure that is commonly used as the first step of treatment for punctal stenosis. METHODS: Clinical, demographic, and outcome data were retrospectively collected for 54 eyes of 21 males and 11 females who consecutively presented to our Oculoplastic Clinic and underwent silicone Micro Flow perforated punctal plug insertion. All patients had epiphora with punctal stenosis. RESULTS: Of the 54 plugs, 26 plugs (48.1%) were lost and 28 (51.8%) stayed in place. Of the latter, eight were explanted because of the occlusion of the plug with secretions and recurrent conjunctivitis; moreover, two plugs migrated deep into the vertical canaliculus. Of the 54 plugs, only 18 (33.3%) were well-tolerated with significant symptomatic improvement. CONCLUSION: Plug loss is a prominent problem in patients implanted with perforated punctal plugs. Silicone punctal plugs failed in 66.7% of our patients over a mean follow-up of 14.2 months.

Evaluating the potential of drug eluting contact lenses for treatment of bacterial keratitis using an ex vivo corneal model.

Corneal infections are treated by multiple instillations of eye drops each day. This study aims to investigate the effectiveness of ofloxacin-loaded contact lenses as prolonged release devices for the treatment of bacterial keratitis. Two silicone hydrogel contact lenses (SHCLs) Senofilcon A (ACUVUE OASYS®) and Narafilcon A (ACUVUE TRUEYE®) were modified by incorporation of ofloxacin alone or with vitamin E (VE). The drug uptake and in vitro release kinetics were investigated and the antibacterial efficacy was assessed against Staphylococcus aureus and Pseudomonas aeruginosa in an ex vivo rabbit corneal model. The in vitro studies showed a higher uptake (p ≤ 0.05) and longer duration of release by Narafilcon A lenses compared to the Senofilcon A lenses. The addition of VE led to a significant increase in duration of release (p < 0.05) for both lenses. The ex vivo studies confirmed the effectiveness of the ofloxacin-loaded lenses in the reduction of bacterial load to clinically insignificant levels and ofloxacin-vitamin E-loaded Narafilcon A lenses in the reduction of bacteria on the corneas to undetectable levels. Antibiotic-loaded lenses are effective in the treatment of ocular infections. Incorporation of vitamin E will sustain this effect and eliminate the need for multiple instillations of eye drops.

Silicone-Based Scar Cream for Post Upper Eyelid Blepharoplasty-associated Cicatricial and Hypertrophic Scarring

PURPOSE: Silicone cream has been shown to improve the appearance of postoperative scars. Nevertheless, surgeons may incorporate intralesional wound modulators such as a triamcinolone and/or 5-fluorouracil (5-FU) for scars that do not completely heal well or those that do not completely respond to other treatment options such as silicone cream. This study sought to determine whether a silicone-based topical scar cream that incorporates selective growth factors can help reduce the incidence of postoperative cicatricial and hypertrophic changes in upper eyelid blepharoplasty incisions. METHODS: This is a single-surgeon, retrospective chart review of patients that underwent a cosmetic upper eyelid blepharoplasty. Subjects were divided into two cohorts depending on whether they received postoperative topical scar cream (SKN2017B) twice daily for 3 months versus no topical scar treatment. Using a modified Vancouver Scar Study Scale for treatment criteria, the incidence of focal intralesional injections of triamcinolone and 5-FU to targeted areas of cicatricial and hypertrophic changes was compared between the two groups. RESULTS: 272 eyelids were identified, of those, 132 eyelids received no treatment and 140 were treated with SKN2017B. 43.9% of eyelids that did not receive treatment underwent intralesional injections of triamcinolone and 5-FU, and 22.9% of eyelids treated with SKN2017B underwent intralesional injections of triamcinolone and 5-FU. The difference between the two groups was found to be statistically significant (P less than 0.05). No adverse reactions were reported from either group. CONCLUSION: The use of a topical silicone-based scar cream has been shown to be safe and effective in decreasing the incidence of intralesional injections of triamcinolone and 5-FU for postoperative cicatricial and hypertrophic changes in upper eyelid blepharoplasty incisions. J Drugs Dermatol. 2019;18(5):440-446.

Mepitel Film and Mepilex Lite for the prophylaxis and treatment of skin toxicities from breast radiation.

Despite the prevalence of radiation dermatitis in breast cancer patients, current practice guidelines for its treatment are limited. We aimed to discuss the quality of evidence for the barrier-forming Mepitel Film for prophylaxis of radiation dermatitis, and argue for further investigation into evidence-based management of skin toxicities. Two studies assessing Mepitel Film were critically evaluated. Both reported that Mepitel Film decreased radiation dermatitis; moreover, patient-reported outcomes significantly favoured Mepitel Film. However, there has not been global adoption of barrier-forming films such as Mepitel, in part due to the absence of multi-centred randomised trials and the heterogeneity of study designs.