To evaluate the efficacy of topical anti-fungal therapy in postoperative cases of COVID Associated Mucormycosis (CAM): A single-blinded randomized control trial

• Published in: American journal of otolaryngology 2023-03, Vol.44 (2), p.103702-103702, Article 103702
• Main Authors: Shaikh, Zaid, Mishra, Abhijeet, Chadaram, Srinivas, Preetam, Chappity, Biswas, Reetika, Adhikari, Asutosh, Alagappan, Alamelu, Parida, Pradipta K., Pradhan, Pradeep, Samal, Dillip Kumar, Mahakud, Sudipta, Hallur, Vinay, Nayak, Anindya, Das, Krishna Kinkar, Chakraborty, Swagata, Sharma, Prity, Veetil, Aswathi Kallyadan, Karakkandy, Vinusree, Mittal, Yash, Chithambaram, Kalyana Sundaram, Swarup, Anurita, Chenniappan, Swathi, Shah, Anwer
• Format: Article
• Language: English
• Subjects: Amphotericin B; COVID-19; Endoscopic staging; Humans; Lipids; Mucormycosis; Mucormycosis - drug therapy; Mucormycosis - surgery; Povidone-Iodine; SARS-CoV-2; Treatment Outcome
• ISSN: 0196-0709; 1532-818X
• DOI: 10.1016/j.amjoto.2022.103702

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. Multi-arm, parallel randomized control trial. The trial was conducted in the Department of ENT, All India Institute of Medical Sciences (AIIMS) Bhubaneswar. 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. 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. Topical Amphotericin-B gel application in the postoperative cavity can decrease the need for revision surgery and help in early recovery. CTRI/2021/10/037257. Clinical Trials Registry of India. •Injudiciou use of corticosteroids during COVID-19 infections is thought to be the leading cause of CAM.•Topical Amphotericin B can be used as successful add on therapy in mucormycosis.•A novel postoperative endoscopic scoring system (AMESS) helps decide the need for revision surgery in case of mucormycosis.