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1.
Am J Otolaryngol ; 44(2):103702, 2022.
Article in English | PubMed | ID: covidwho-2158378

ABSTRACT

PURPOSE: To compare the efficacy of 0.1 % w/w Liposomal Amphotericin-B gel with 10 % w/w Povidone-Iodine and saline nasal douching in preventing revision surgery in patients with CAM. STUDY DESIGN: Multi-arm, parallel randomized control trial. STUDY SETTING: The trial was conducted in the Department of ENT, All India Institute of Medical Sciences (AIIMS) Bhubaneswar. METHODS: Participants: Microbiologically and histologically proven cases of mucormycosis who underwent surgical debridement were included in the study. INTERVENTIONS: Postoperatively, patients were randomized into three groups based on the type of topical intervention received, in the form of Lipid-based Amphotericin B gel, povidone‑iodine ointment or saline nasal douching. OUTCOME: Requirement of revision surgery in postoperative cases of CAM. RANDOMIZATION: Participants were allotted to one of the three arms by block randomization. BLINDING: Single-blinded trial. RESULTS: Numbers randomized: 15 participants were randomized to each group. Recruitment: Completed recruiting. Numbers analyzed: 15 participants were analyzed in each group. OUTCOMES: Control arm's risk of revision surgery was 4.50 (95 % CI: 1.16-17.44) times than Lipid-based Amphotericin B gel arm and 1.50 (95 % CI: 0.71-3.16) times that of the Povidone- Iodine arm. The difference was statistically significant (p = 0.02) for Amphotericin but not for Povidone-Iodine. CONCLUSIONS: Topical Amphotericin-B gel application in the postoperative cavity can decrease the need for revision surgery and help in early recovery. TRIAL REGISTRATION: CTRI/2021/10/037257. Clinical Trials Registry of India.

2.
J Laryngol Otol ; 136(12): 1309-1313, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2076940

ABSTRACT

OBJECTIVE: Rhino-orbito-cerebral mucormycosis is a rapidly progressive disease with high mortality rates of about 60 per cent. The increasing incidence of rhino-orbito-cerebral mucormycosis in coronavirus disease 2019 patients in India and worldwide has become a matter of concern owing to the case fatality rate. This study explored the use of low dose aspirin in decreasing the mortality rate of coronavirus disease 2019 associated mucormycosis. METHOD: This was a retrospective observational study. Patients suffering from post-coronavirus disease 2019 mucormycosis were included in the study. Each patient was treated with surgical debridement and systemic amphotericin B. Low dose aspirin was added, and mortality rates were compared with the patients who did not receive aspirin. RESULTS: The demographic data and rhino-orbito-cerebral mucormycosis staging between the two groups were not significantly different. There was a statistically significant difference in mortality outcomes between the two groups (p = 0.029) and a 1.77 times higher risk of dying for patients not receiving aspirin. Kaplan-Meier survival indicated that patients receiving aspirin had better survival rates (p = 0.04). CONCLUSION: Low dose aspirin improves survival rates in coronavirus disease 2019 associated mucormycosis.


Subject(s)
COVID-19 , Mucormycosis , Orbital Diseases , Humans , Mucormycosis/drug therapy , Retrospective Studies , Aspirin/therapeutic use , Antifungal Agents/therapeutic use , Debridement
3.
Otolaryngology - Head and Neck Surgery ; 167(1 Supplement):P141-P142, 2022.
Article in English | EMBASE | ID: covidwho-2064502

ABSTRACT

Introduction: COVID-19-associated mucormycosis (CAM) is an ongoing epidemic that adds to COVID-19 woes in several countries. Mucormycosis is a fulminant angioinvasive fungal disease for which surgical debridement with systemic antifungal therapy is advocated. The efficacy of using topical antifungal therapy in the form of lipid-based amphotericin B gel and povidone-iodine is compared in the trial. Method(s): This is a multiarm, parallel randomized control trial. Microbiologically and histologically proven cases of mucormycosis in patients who underwent open or endoscopic surgical debridement were included in the study. The trial was conducted in the in-patient ear, nose, throat department of a tertiary care referral hospital in eastern India, All India Institute of Medical Sciences, Bhubaneswar, from May to December 2021. The postoperative cavity was treated according to the intervention arm in the form of lipid-based amphotericin B gel, povidone-iodine ointment, or saline nasal douching according to the allotted group. The aim was (1) to compare the efficacy of 0.1% w/w liposomal amphotericin B gel with 10% w/w povidone-iodine and saline nasal douching in preventing revision surgery in patients with CAM and (2) to develop the AIIMS Bhubaneswar Endoscopic Scoring System (AMESS) to quantify response to treatment. The requirement of revision surgery in postoperative cases of CAM was assessed. Result(s): Fifteen participants were analyzed in each group. The control arm's risk of revision surgery was 4.50 (95% CI, 1.16-17.44) times than the lipid-based amphotericin B gel arm and 1.50 (95% CI, 0.71-3.16) times than povidone-iodine arm. The difference was statistically significant (P=.02) for amphotericin but not for povidone-iodine. The absolute risk reduction of applying amphotericin gel is 46.7%, and number needed to treat is 2.14. Conclusion(s): Topical amphotericin B gel application in the postoperative cavity can decrease the need for revision surgery and help in early recovery. However, long-term studies with greater sample size are required to confirm our findings.

4.
Otolaryngology - Head and Neck Surgery ; 167(1 Supplement):P281-P282, 2022.
Article in English | EMBASE | ID: covidwho-2064420

ABSTRACT

Introduction: India is one of the countries most affected by COVID-19. COVID-19-associated mucormycosis (CAM) has added to the woes of the already devastating effects of the virus. About 97.6% of cases in India presented with rhino-orbito-cerebral disease. Fibrous dysplasia (FD) is characterized by abnormal mixtures of fibrous and osseous elements leading to bony deformities and pathological fractures. Monostotic and polyostotic varieties have been described, with the latter being more common in children. The monostotic type of FD accounts for about 70% to 80% of FD, affecting the second and third decade. Method(s): We present a case of 44-year-old man with fibrous dysplasia of left maxilla with CAM, an angioinvasive fungal disease associated with high morbidity and mortality. As India and the entire world is struck by the COVID-19 pandemic, the use of corticosteroids has proven somewhat helpful in managing severe COVID infection. Evidence shows it has also led to CAM. Our patient was treated with radical surgical treatment of lesion with gross removal of all necrotic tissues from the sinuses along with antifungal treatment with amphotericin B. FD is a benign disorder characterized by replacement of normal bone with cellular fibrous connective tissue. Result(s): Our case presented with CAM of maxilla with palatal involvement requiring urgent surgical intervention and antifungal therapy. It incidentally happened to be a case of FD. Maxillectomy took care of the patient's FD as well. Conclusion(s): FD is a disorder characterized by dystrophy and bony metaplasia, and treatment depends on the zone of involvement. Early diagnosis and surgical intervention, with good antifungal therapy with strict glycemic control, are critical features to prevent its onslaught. Sometimes treatment of one condition can cure the others as well.

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