A Case Report and Pediatric Literature Review: Povidone as a Rare Cause of Anaphylaxis in Children.

Background: Povidone, a synthetic polymer commonly used in various products such as antiseptics, cosmetics, and medications, has been associated with allergic reactions, including anaphylaxis. Despite its widespread use, cases of povidone-induced anaphylaxis, especially in children, are under-recognized. This case report aims to highlight the importance of considering povidone allergy in pediatric patients presenting with anaphylaxis. Case Presentation: We describe a 3-year-old boy who experienced anaphylaxis following the application of povidone-iodine antiseptic solution to a leg wound. He presented with generalized urticaria, angioedema, dyspnea, and cough. Prompt diagnosis and management were initiated in the emergency department. He experienced the second anaphylaxis with povidone-containing eye drops prescribed during an ophthalmology visit. Conclusions: Povidone allergy should be considered in pediatric patients presenting with anaphylaxis, especially those with idiopathic reactions or multiple drug allergies. Clinicians should emphasize patient education on label reading and the provision of adrenaline autoinjectors to prevent life-threatening reactions associated with povidone exposure.

Phase 1 study of the iodine absorption, safety, and tolerability of a 0.5% povidone-iodine nasal spray (Nasodine).

KEY POINTS: PVP-I is a widely used antiseptic but only recently proposed for intranasal use. The extent of iodine absorption from available PVP-I nasal products is unknown. Iodine absorption from use of Nasodine (0.5% PVP-I nasal spray) is not clinically significant.

[Quality of life survey of 3,738 patients treated with intravitreal injections for age-related macular degeneration]. / Enquête de qualité de vie auprès de 3738 patients traités par injections intravitréennes pour leur dégénérescence maculaire liée à l'âge.

PURPOSE: To evaluate the peri- and post-intravitreal injection (IVI) symptoms reported by patients who have been repeatedly injected for age-related macular degeneration (AMD) and to analyze these according to the protocols of the injector. MATERIALS AND METHODS: Multi-center, cross-sectional, consecutive, analytical survey. RESULTS: The IVI protocols of 106 injectors differed in terms of the number of instillations of povidone-iodine, its contact time, and rinsing of the ocular surface post-injection. In total, 3,738 patients responded to the survey, 60.1% of whom were women; 36.4% had received more than 20 IVIs; 50.7% of patients reported irritation upon application of povidone-iodine. Post-IVI, depending on the symptom in question, between 44.8% and 57.4% of patients reported symptoms of ocular surface change. The number of instillations of povidone-iodine, its contact time with the ocular surface, and abundant rinsing post-IVI increased the immediate symptoms. Patients who received more IVIs were more prone to experiencing gritty eyes, and the incidence of acute pain increased in patients who had previously received over 20 IVIs. Women and patients previously treated for dry eye or glaucoma were at greater risk of worse symptoms. CONCLUSION: Comparing injecting centers' practices with patients' self-assessments showed an aggravation of symptoms of ocular surface changes related to povidone-iodine. This survey contributes to providing data for the implementation of a protocol to improve the quality of life of patients injected repeatedly for AMD.

Iodine-induced hypothyroidism (IIH) in paediatric patients receiving peritoneal dialysis: Is risk mitigation possible?

Children with kidney failure who receive maintenance peritoneal dialysis (PD) are at increased risk for thyroid dysfunction. A poorly appreciated cause of hypothyroidism related to PD is iodine overload from exposure to iodine-containing cleaning solutions, iodinated contrast agents or povidone-iodine-containing PD caps, particularly in infants and small children. An international survey was conducted to understand current practices regarding iodine exposure in PD patients, the frequency of iodine-induced hypothyroidism (IIH) in patients receiving PD, and to assess awareness of this issue among paediatric nephrologists. Eighty-nine paediatric nephrology centres responded to the survey. Hypothyroidism in PD patients was diagnosed in 64% (n = 57) of responding centres, although only 19 of these centres (33%) suspected or diagnosed IIH. Aetiologies of IIH included exposure to povidone-iodine-containing PD caps (53%), cleaning solutions with iodine (37%) and iodinated contrast (10%). While most centres (58%, n = 52) routinely evaluate thyroid function, only 34% (n = 30) specifically aim to limit iodine exposure. Of centres not routinely evaluating for or utilising methods to prevent iodine exposure and hypothyroidism, 81% reported being unaware of the risk of IIH in PD patients. Hypothyroidism is diagnosed in a substantial percentage of paediatric PD programmes internationally. Increased education on the risk of iodine exposure in children receiving PD may decrease the incidence of IIH as an aetiology of hypothyroidism.

Povidone-iodine-induced transient triiodothyronine thyrotoxicosis in a Japanese patient with prolonged habitual gargling: A case report and literature review.

RATIONALE: Iodine-induced hyperthyroidism and triiodothyronine (T3) thyrotoxicosis in patients who routinely gargle with povidone-iodine (PVP-I) gargling solution are rare in Japan. PATIENT CONCERNS: A 50-year-old man presented to our hospital for a close examination of an enlarged thyroid, which was noted during a complete health checkup. The thyroid was slightly enlarged with no palpable nodules. He had an increased appetite but no weight gain. He had been routinely gargling with PVP-I gargling solution 4 times daily for >10 years. He had no history of thyroid disease. DIAGNOSES: Test results revealed suppressed thyroid-stimulating hormone, normal free thyroxine, and increased free triiodothyronine levels, leading to the diagnosis of T3 thyrotoxicosis. INTERVENTIONS: The patient agreed to stop gargling with PVP-I gargle solution. OUTCOMES: The free triiodothyronine and thyroid-stimulating hormone levels returned to normal at 18 and 21 weeks, respectively, after discontinuation of PVP-I gargling. After an improvement in thyroid function, he gained 5 kg in 1 year. LESSONS: To our knowledge, this is the first case report that describes PVP-I gargle-induced T3 thyrotoxicosis in a healthy individual without thyroid disease. In Japan, which is an iodine-sufficient country, considering the possibility of high-dose iodine intake-induced thyrotoxicosis due to long-term PVP-I gargling or other causes is necessary, even in individuals with no history of thyroid disease.

Efficacy and safety of doxycycline versus iodopovidone for pleurodesis through an intercostal tube in malignant pleural effusions: a randomized trial.

PURPOSE: The search for an inexpensive agent for chemical pleurodesis in malignant pleural effusion (MPE) continues. We aimed to compare the efficacy and safety of iodopovidone versus doxycycline for pleurodesis in MPE. METHODS: We randomized consecutive subjects with recurrent symptomatic MPE (1:1) to undergo pleurodesis with either doxycycline or iodopovidone administered through an intercostal tube. The primary outcome was the success rate of pleurodesis at 30 days. The secondary outcomes were the time to pleurodesis, chest pain (assessed using visual analog scale [VAS]) after pleurodesis, and complications (hypotension, acute respiratory failure, empyema). RESULTS: We randomized 52 and 58 subjects to receive either doxycycline or iodopovidone. The mean (standard deviation [SD]) age of the study population (51% women) was 54.1 (13.6) years. Lung cancer (≥ 60%) was the most common underlying cause of MPE. We observed a similar frequency of success in the doxycycline vs. the iodopovidone group (complete response: 43 (82.7%) vs. 46 (79.3%) subjects; partial response: 7 (13.5%) vs. 10 (17.2%) subjects; p = 0.3). The mean (SD) time to pleurodesis was 1.5 (1.9) days and 1.9 (5.4) days in the doxycycline and iodopovidone groups, respectively. While the VAS for chest pain was significantly higher with iodopovidone (mean [SD] VAS: doxycycline, 31.9 [20.9]; iodopovidone, 41.3 [21.8]; p = 0.017), it did not reach the minimal clinically important difference. The complication rates were similar between the two groups. CONCLUSION: Iodopovidone was not superior to doxycycline for pleurodesis in MPE. TRIAL REGISTRATION NUMBER/DATE: clinicaltrials.gov (NCT02583282) / October 22, 2015.

A comparison of chlorhexidine and povidone-iodine solutions in neonatal intensive care units.

BACKGROUND: Povidone-iodine (10%; PI) and 2% chlorhexidine in 70% isopropyl alcohol (CHG-IA) solutions are among the most widely used disinfectants in the neonatal intensive care units. This study compares the use of these disinfectants and helps decide which is superior to the other for neonatal use. METHODS: All term and preterm infants born and hospitalized in Bursa Uludag University Hospital between July 2018-March 2020 were included. The infants were randomized into two disinfectant groups before birth. The application site was cleaned with the assigned disinfectant before intervention. The infants were screened for rates of neonatal sepsis, thyroid-stimulating hormone (TSH) levels, free thyroxine (fT4) levels, skin reactions to the assigned solution, and acute neurological side effects. RESULTS: We enrolled 208 term and preterm infants (PI:104 vs. CHG-IA: 104) in the study. The prematurity rates were identical (PI: 74.0%; CHG-IA: 72.1%; p = 0.755). Neonatal sepsis rates among these groups were not statistically different (PI: 8.7%; CHG-IA: 4.8%; p = 0.406). The median TSH value of the PI group was high (4.05 mIU/L) in comparison with that of the CHG-IA group (3.09 mIU/L; p = 0.016). No cutaneous or neurological side effects were recorded in patients treated with CHG-IA solution. CONCLUSIONS: Although these two solutions were equally protective against infections, the CHG-IA solution was a better alternative to PI for neonatal use. Considering that the PI solution may be responsible for impaired thyroid function, the CHG-IA solution is a good alternative because it provides sufficient protection with a safer adverse effect profile.

Accelerative Wound-Healing Effect of Aqueous Anthocephalus Cadamba Leaf Extract in a Diabetic Rat Model.

Impaired wound healing is a major concern in diabetic patients due to unregulated chronic hyperglycemia which further may lead to ulcer, gangrene, and its complications. The present study unveils the accelerative effect of aqueous Anthocephalus cadamba leaf extract on wound healing in diabetic rats. Diabetes was induced in 30 Sprague Dawley female rats by using streptozotocin (except control group I) at the dose of 60 mg/kg intraperitoneally. Diabetic rats were randomized in 3 groups viz. diabetic control group (II), diabetes + Kadam plant leaf extract group (III), and diabetes + 5% povidone-iodine solution group (IV). Surgically sterile wound of 1.77 cm2 was created on the dorsal area of anaesthetized rats. The experimental parameters were assessed by hematobiochemical, histopathological, and western blot techniques. The A cadamba extract treatment group (III) (D + KPLE) showed a significant increase in the percentage of wound closure (82%) at day 21 as compared to the diabetic control group (42%), nondiabetic control group (I) (49%), and povidone-iodine treatment group (75%) group (IV). The findings of the present study suggest that the (D + KPLE) group (III) exhibited marked epithelial regeneration, neovascularization, collagen deposition, and fibroblast proliferation along with higher expression of vascular endothelial growth factor as compared to the diabetic control group (II), which was confirmed by histopathological examination and western blot analysis. The present study suggests that the topical application of aqueous A cadamba leaf extract exhibits accelerative wound-healing properties in diabetic rats.

Rhinoplasty in the COVID-19 Era: Practice and Safety Considerations.

SUMMARY: The COVID-19 pandemic has required changes in health care practices to decrease the risk of disease transmission during the provision of medical care. The risk of transmission is high in procedures involving the nasopharyngeal and oropharyngeal tissues. This article describes simple preventative strategies at a single institution to minimize the risk of disease transmission during rhinoplasty procedures. In particular, the utility of povidone-iodine in prophylaxis during the perioperative period is discussed.

Stable thyroid function despite regular use of povidone-iodine throat spray for SARS-CoV-2 prophylaxis.

BACKGROUND: It is unclear whether unintentional ingestion of povidone-iodine following its application to the oropharyngeal space could affect thyroid function. OBJECTIVE: To examine thyroid function among individuals who regularly apply povidone-iodine throat spray for SARS-CoV-2 prophylaxis. METHODS: We designed a case-control study to compare thyroid function among participants who received povidone-iodine throat spray three times a day for 42 days ('cases') and those who received vitamin C ('controls'). Thyroid function was assessed by profiling serum TSH, free T3, and free T4; iodine status was estimated using serum thyroglobulin level, while infection status was determined by measuring anti-SARS-CoV-2 antibody against the nucleocapsid antigen. All measurements were performed in pairs, at baseline and 42 days later. Pre-post changes in thyroid function were compared between groups, before and after stratification according to baseline TSH quartiles. RESULTS: A total of 177 men (117 cases and 60 controls) (mean age, 32.2 years) were included. Despite comparable demographics and clinical profiles, no clinically or statistically significant differences were observed in thyroid indices between 'cases' and 'controls' before and after stratification according to TSH quartiles. None of the participants developed symptomatic hypo- or hyperthyroidism throughout the study. Post-hoc analysis did not reveal differences in thyroid function according to infection status. CONCLUSIONS: Data from this study support the overall safety of povidone-iodine use in the oropharyngeal space for SARS-CoV-2 prophylaxis among individuals with normal thyroid function and subclinical thyroid disease.

Comparison of different concentrations of a povidone iodine-diluted sitz bath in the prevention of perianal infection in patients undergoing chemotherapy for hematological malignancy: study protocol for a randomized controlled trial.

BACKGROUND: Infection is one of the most common causes of death in patients with hematological malignancies during chemotherapy. Due to its special location, local warmth and humidity, repeated pollution with stool and urine, and characteristically wrinkled anatomical structure within which bacteria can hide, the perianal becomes a site with a high incidence of infection. Such infection also has a high recurrence rate and high mortality, increasing the economic burden of patients, delaying the time of treatment and reducing the quality of life. In severe cases, sepsis occurs and endangers the patient's life. Previous studies have confirmed the effectiveness of povidone iodine (PI) in the prevention of perianal infection in patients with hematological malignancies during chemotherapy, but these reports have not documented in detail the adverse events associated with sitz bathing and the lack of randomized controlled trials of different concentrations of dilute povidone iodine sitz bathing. Therefore, the evidence is insufficient. Hence, the objective of this paper is to determine whether a povidone iodine diluent sitz bath can reduce the incidence of perianal infection compared with conventional perianal cleaning care and to observe the incidence of perianal infection, the severity of perianal infection, and the complications related to the sitz bath among groups treated with different concentrations of povidone iodine diluent, especially in high-risk patients prone to perianal infection, to screen for the optimal concentration. METHODS: The trial is designed as a single-center, parallel, randomized, controlled and intervention trial with four parallel groups, and a primary endpoint of perianal infection occurred after this hospitalization chemotherapy. Randomization will be performed as simple randomization with a 1:1:1:1 allocation. This study received full ethics committee approval. The first patient was enrolled on May 1, 2021. A total of 268 patients with hematological malignancies undergoing chemotherapy who have risk factors for perianal infection will be enrolled with informed consent and randomly allocated to one of the four arms receiving (1) perianal cleaning care (control group D), (2) 1:100 PI diluted sitz bath (intervention group A), (3) 1:200 PI diluted sitz bath (intervention group B), and (4) 1:300 PI diluted sitz bath (intervention group C). The primary endpoint of the trial was the incidence of perianal infection. The secondary endpoints of the study will be the results of anal swab bacterial culture, the severity of perianal infection, the incidence of perianal adverse events (dryness, peeling, pigmentation, burning sensation), and pain scores. The length of hospitalization in days and hospitalization expenses will be recorded. Safety will be assessed with consideration of all adverse and severe adverse events related to the study treatment. DISCUSSION: We hypothesized that patients with hematological malignancies during chemotherapy would benefit from a povidone iodine diluted sitz bath. This study will provide evidence-based recommendations for clinicians and nurses. TRIAL REGISTRATION: Chinese Clinical Trial Registry (registration ID: ChiCTR2000041073). Registered on December 17, 2020. The protocol version number is V1.0,20201217. http://www.chictr.org.cn/edit.aspx?pid=66044&htm=4.

A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan.

BACKGROUND: Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. METHODS AND DESIGN: The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. RESULTS: The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. CONCLUSION: This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.

Implants and Breast Pocket Irrigation: Outcomes of Antibiotic, Antiseptic, and Saline Irrigation.

BACKGROUND: Breast implant-associated infection and capsular contracture are challenging complications that can result in poor outcomes following implant-based breast surgery. Antimicrobial irrigation of the breast pocket or implant is a widely accepted strategy to prevent these complications, but the literature lacks an evidence-based consensus on the optimal irrigation solution. OBJECTIVES: The objective of this systematic review was to compare clinical outcomes, specifically capsular contracture, infection, and reoperation rates, associated with the use of antibiotic, antiseptic, and saline irrigation. METHODS: A systematic review was performed in March 2020 based on the following search terms: "breast implant," "irrigation," "antibiotic," "bacitracin," "antiseptic," "povidone iodine," "betadine," "low concentration chlorhexidine," and "hypochlorous acid." Capsular contracture, infection, and reoperation rates were compared by analysis of forest plots. RESULTS: Out of the 104 articles screened, 14 met the inclusion criteria. There was no significant difference in capsular contracture rates between antibiotic and povidone-iodine irrigation, although the data comparing these 2 groups were limited and confounded by the concurrent use of steroids. Antibiotic irrigation showed a significantly lower rate of capsular contracture compared with saline irrigation and a lower rate of capsular contracture and reoperation compared with no irrigation at all. Povidone-iodine was associated with lower rates of capsular contracture and reoperation compared with saline irrigation but there were no data on infection rates specific to povidone-iodine irrigation. CONCLUSIONS: Our study supports the use of antibiotics or povidone-iodine for breast implant irrigation. Further research is required to better determine which of these 2 irrigation types is superior.

Effectiveness and safety of povidone iodine for prolonged lung air-leak after lung surgery.

BACKGROUND: Pulmonary surgery is often associated with postoperative prolonged parenchymal air-leak. The purpose of this study was to determine efficacy and safety of povidone iodine as treatment of prolonged parenchymal air-leak following all-types of lung surgery. METHODS: This prospective trial was conducted from June 2019 to December 2020, and designed under PanAfrican Clinical Trials Registry requirements. Patients having prolonged parenchymal air-leak were randomly allocated to povidone iodine protocol (Group A) or surveillance without povidone iodine (Group B). We collected the number of povidone iodine injections required before bubbling stopped, total drainage period, tolerance after injection, complications and side-effects. Comparative study was performed to evaluate povidone iodine efficacy. RESULTS: Following randomization, Group A included 19 patients, and Group B 21. Both groups were comparable. The mean drainage period was 9.21 days in Group A (6-14 days) and 15.62 days in Group B (7-31 days) (p = 0.001). The mean hospitalization period was 11.05 days in Group A (7-16 days) and 18.9 days in Group B (9-38 days) (p < 0.0001). The mean follow-up period was 6.8 months (3-18 months). No deaths were noted in either groups. Four side-effects were reported in Group A (21%) and four serious complications were noticed in Group B (19%). No recurrences were reported in Group A versus one recurrence of homolateral pneumothorax in Group B (4.76%). CONCLUSIONS: Povidone iodine is an effective and safe solution for pleurodesis. It is associated with a low complication rate that remains acceptable, and could be proposed as treatment of prolonged parenchymal air-leak after lung resections.

Regression discontinuity of blood culture contamination rate after changing of disinfectants: retrospective observational study.

Blood cultures are indispensable for detecting life-threatening bacteremia. Little is known about associations between contamination rates and topical disinfectants for blood collection in adults. We sought to determine whether a change in topical disinfectants was associated with the rates of contaminated blood cultures in the emergency department of a single institution. This single-center, retrospective observational study of consecutive patients aged 20 years or older was conducted in the emergency department (ED) of a university hospital in Japan between August 1, 2018 and September 30, 2020. Pairs of blood samples were collected for aerobic and anaerobic culture from the patients in the ED. Physicians selected topical disinfectants according to their personal preference before September 1, 2019; alcohol/chlorhexidine gluconate (ACHX) was mandatory thereafter, unless the patient was allergic to alcohol. Regression discontinuity analysis was used to detect the effect of the mandatory usage of ACHX on rates of contaminated blood cultures. We collected 2141 blood culture samples from 1097 patients and found 164 (7.7%) potentially contaminated blood cultures. Among these, 445 (20.8%) were true bacteremia and 1532 (71.6%) were true negatives. Puncture site disinfection was performed with ACHX for 1345 (62.8%) cases and with povidone-iodine (PVI) for 767 (35.8%) cases. The regression discontinuity analysis showed that mandatory ACHX usage was significantly associated with lower rates of contaminated blood cultures by 9.6% (95% confidence interval (CI): 5.0%-14.2%, P < 0.001). Rates of contaminated blood cultures were significantly lower when ACHX was used as the topical disinfectant.

Chlorhexidine-alcohol versus povidone-iodine as preoperative skin antisepsis for prevention of surgical site infection in cesarean delivery-a pilot randomized control trial.

OBJECTIVES: To compare the efficacy of chlorhexidine-alcohol and povidone-iodine as preoperative antiseptic skin preparation for prevention of surgical site infection (SSI) after cesarean delivery (CD). MATERIALS AND METHODS: A total of 311 eligible women who underwent CS were recruited in the study after fulfilling all the eligibility and exclusion criteria. Patients were randomized into two groups (153 in chlorhexidine-alcohol group and 158 in povidone-iodine group) by a computer-generated randomization table. Patients were followed for a period of 30 days in postoperative period to monitor for SSI. RESULTS: The rate of SSI in the chlorhexidine-alcohol group is 5.4% and that of the povidone-iodine group is 8.6%. E. coli, K. pneumoniae, and Acinetobacter baumannii were the most common organisms isolated. E. coli was found in 9.5% of the total SSI cases. CONCLUSIONS: The study found that the patients who received chlorhexidine-alcohol as skin antiseptic had less chance of developing SSI than those who received povidone-iodine; however, it did not reach a statistical significance. TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2018/05/014294 . Registered on May 31, 2018.