The Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmers: Double-blind Randomized Clinical Trial

BackgroundLong-term sun exposure is one of the risks faced by outdoor swimmers and can cause sunburn. Using sunscreen is one way to prevent sunburn; however, physical activity can trigger sweat, friction, and water washing that can interfere with sunscreen efficacy and decrease its sun protection factor (SPF). Sunscreens are classified into inorganic and organic based on their filter. Organic sunscreen has a better bond to the skin than inorganic sunscreen, which forms a barrier above the skin layer that makes removing it easier. Organic sunscreen lasts longer than inorganic sunscreen when used in physical activities, but it has a limited spectrum, is more photolabile, and is more allergenic. ObjectiveThis study aims to evaluate the persistency of SPF 30 between inorganic and organic sunscreens on the back area after 1.5 hours of swimming. MethodsThis study is a randomized, split-body, double-blind clinical trial to evaluate the persistency of SPF 30 of the inorganic versus organic sunscreens in swimmers. Randomization was done to allocate the participants into treatment groups. Each participant received inorganic and organic sunscreen treatments applied to the back area. The research participants were swimmers from the Cikini swimming pool and Bina Taruna swimming pool, both in Jakarta, Indonesia. ResultsA total of 22 swimmers were enrolled in this study. The analysis showed no significant difference between the SPF of the two sunscreens before swimming (P=.22). After swimming, the SPF levels of both sunscreens decreased: the inorganic sunscreen decreased from a median of 27 (range 23-47) to 12.3 (range 8-19), and the organic sunscreen decreased from a median of 30 (range 24-47) to 9.9 (range 6-19), which was statistically significant (P<.001). When comparing the SPF of inorganic and organic sunscreens after swimming, there was a statistically significant difference in the decrease in SPF levels between the two groups (P=.02), which indicated a better SPF persistence for inorganic sunscreens when compared to organic sunscreens. ConclusionsThere was a decrease in the SPF levels of inorganic and organic sunscreens after 1.5 hours of swimming, with better persistence in inorganic sunscreens compared to organic sunscreens. Trial RegistrationClinicalTrials.gov NCT04618536; https://clinicaltrials.gov/ct2/show/NCT04618536 International Registered Report Identifier (IRRID)RR2-10.2196/4250

Reconstruction of a huge frontal defect caused by a mucocele with a combination of autologous graft and titanium mesh: A case report

Introduction: Reconstruction of frontal deformities is challenging for surgeons, with the search for materials and techniques that offer a more comfortable and optimal result being a significant issue. This report describes the reconstruction of a large frontal defect caused by a mucocele using a titanium mesh and rib cartilage. Case: A 44-year-old female with a left frontal ethmoid mass was suspected of having a mucocele with a frontal defect and optic nerve compression. The patient underwent drainage, endoscopic marsupialization of the mucocele, and reconstruction of the frontal defect using a combination of a rib graft and titanium mesh. The patient showed no complications or functional or esthetic complaints over one year of follow-up. Discussion: Autologous bony cartilage has great growth potential and functions best when integrated into the natural bone, indicating a reduced risk of graft loss. Titanium is a non-inflammatory, biocompatible metal that is helpful for the quick repair of large cranial defects. In the present case, the frontal defect was large. Therefore, we decided to use a rib graft combined with a titanium mesh as a bridge to close the defect. Conclusion: Reconstruction of a frontal defect using a combination of autologous rib grafts and titanium mesh showed excellent results in the current case

Comparison of Sun Protection Factor (SPF) 30 Persistence Between Inorganic and Organic Sunscreen in Swimmers: Protocol for a Multicenter, Randomized, Noninferiority, Split-Body, Double-Blind Clinical Trial

BackgroundOutdoor swimming athletes are often exposed to undesirable environmental conditions such as long-term sun exposure. The risk of sunburn can still occur in this population due to the loss of sunscreen and an increase in the sensitivity of the skin to ultraviolet rays, particularly ultraviolet B, in wet conditions. Some previous trials showed that organic sunscreens had a longer shelf-life than inorganic sunscreens after exercise due to their characteristics to bind better with the skin layer. Meanwhile, inorganic sunscreens tend to form layers on the skin’s surface so that they can be more easily removed. To our knowledge, no studies evaluate sunscreens' resistance, either inorganic or organic, after exercising in Indonesia. ObjectiveThis study aims to evaluate the persistence of inorganic versus organic sunscreens used by swimmers. The primary objective is to assess whether the inorganic sunscreen is as good as the organic sunscreen in the field of the persistence of sunscreens after swimming for 1.5 hours. MethodsThis study is a randomized, split-body, double-blind, noninferiority, and multicenter clinical trial in Cikini, Jakarta, Indonesia. An estimated 22 athletes in each group, who aged 18-40 years and practice in the morning or afternoon, will be randomized using a computer-generated randomization method. We calculated the sample size using the difference in the average decrease in sun protection factor (SPF) levels that is considered significant based on the clinical judgment set by the researchers, which was 5. Neither the research subjects nor the researchers are aware of the type of sunscreen that will be applied. The hypothesis will be tested using paired-sample t test or Wilcoxon to assess the difference of SPF levels in each group between organic and inorganic sunscreens with SPSS (version 20.0; IBM Corp). ResultsThis study has been approved by the Ethical Committee Faculty of Medicine Universitas Indonesia and is funded by the International Publication Grant from Universitas Indonesia. The enrollment process was completed in December 2020. ConclusionsThis study will test all procedures in preparation for conducting the main study, including several potential obstacles and challenges from the perspective of participating physicians and eligible swimmers. The study results will be disseminated through publications in a peer-reviewed journal with Open Access format. This study will provide information about SPF 30 persistence in sunscreens and the best type of sunscreen to be used while swimming, particularly for athletes. Trial RegistrationClinicalTrials.gov NCT04618536; https://clinicaltrials.gov/ct2/show/NCT04618536?term=NCT04618536 International Registered Report Identifier (IRRID)RR1-10.2196/4250

Validity and reliability of the Indonesian version of tinnitus handycap inventory

Background: To translate and assess the validity and reliability of the Indonesian version of Tinnitus Handycap Inventory (THI) as an psychometric instrument for evaluating the quality of life in tinnitus patients. This instrument will support the clinicians to determine the appropriate tinnitus management for them.Methods: A cross-sectional psychometric validation study was performed to assess the internal consistency, reliability and validity of the Indonesian version of THI in 50 subjective tinnitus patients at ENT outpatient clinic of Cipto Mangunkusumo Hospital between May-August 2010. 25 question items of original THI were translated, back-translated and validated using the transcultural validation by WHO.Results: The validity test demonstrated a significant correlation in the emotional and the catastrophic scale whilst there was no significant correlation in the functional scale for item F2 and particularly for item F15. Nevertheless, the validity test on the functional scale showed a good result. This study also showed high internal consistency and reliability for the total scale (Cronbach-α = 0.91)Conclusion: The evaluation result indicated that the reliability of adapted Indonesian version of the THI in our study is relatively high and could be applied in clinical examination or further otolaryngology study by both specialists and general physicians.</p

Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study (OPAL study)

Abstract Background Acute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, for which antibiotics are frequently prescribed. However, antibiotics are beneficial for only one third of AOM cases, and then, with only modest benefit. Since antibiotic use leads to risk of side effects and resistance, effective alternative treatments are required. Corticosteroids are a candidate because of their anti-inflammatory effects, although evidence of their efficacy and harms is insufficient. Accordingly, we plan a large, rigorous clinical trial to test this. Initially, we will test pre-specified methods and procedures (including the overall process, resources, management, and scientific components) in a pilot study of corticosteroids for AOM, which will inform a future, definitive trial. Methods This is a pilot pragmatic, randomised, open-label, single-blind, controlled study of corticosteroids as either monotherapy or an addition to antibiotics in 60 children aged 6 months to 12 years with AOM in two cities (Jakarta and Bekasi) in Indonesia. We will randomise eligible children to prednisolone or control. We will also stratify by disease severity and randomise those with mild AOM to expectant observation plus prednisolone or observation alone and those with severe AOM to prednisolone plus antibiotic or antibiotic alone. Our outcomes are to determine (1) recruitment rates, (2) the success of the study procedures, (3) the ability to measure planned outcomes of the proposed main study, (4) the compliance to study visits and study medication, and (5) verification of the sample size calculation for the main study. We will also assess middle ear effusion using tympanometry as part of a mechanistic sub-study. Discussion This study will test all procedures in preparation for the main study, including several potential obstacles and challenges from the perspective of participating physicians, nurses, pharmacists, and the parents of eligible children. This information will be useful for developing strategies to overcome practical and procedural issues. This study may also provide information about the effects of corticosteroids on middle ear effusion in AOM. Trial registration Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018