학술논문
To evaluate the efficacy of topical anti-fungal therapy in postoperative cases of COVID Associated Mucormycosis (CAM): A single-blinded randomized control trial.
Document Type
Academic Journal
Author
Shaikh Z; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Mishra A; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Chadaram S; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Preetam C; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India. Electronic address: preetam82@gmail.com.; Biswas R; Department of Community and Family Medicine, All India Institute of Medical Sciences, Bhubaneswar, India.; Adhikari A; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Alagappan A; Department of Radiodiagnosis, All India Institute of Medical Sciences, Bhubaneswar, India.; Parida PK; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Pradhan P; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Samal DK; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Mahakud S; Department of Radiodiagnosis, All India Institute of Medical Sciences, Bhubaneswar, India.; Hallur V; Department of Microbiology, All India Institute of Medical Sciences, Bhubaneswar, India.; Nayak A; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Das KK; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Chakraborty S; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Sharma P; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Veetil AK; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Karakkandy V; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Mittal Y; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Chithambaram KS; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Swarup A; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Chenniappan S; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.; Shah A; Department of ENT and HNS, All India Institute of Medical Sciences, Bhubaneswar, India.
Source
Publisher: Saunders Country of Publication: United States NLM ID: 8000029 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-818X (Electronic) Linking ISSN: 01960709 NLM ISO Abbreviation: Am J Otolaryngol Subsets: MEDLINE
Subject
Language
English
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.
Competing Interests: Declaration of competing interest The authors have no conflict of interest.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
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.
Competing Interests: Declaration of competing interest The authors have no conflict of interest.
(Copyright © 2022 Elsevier Inc. All rights reserved.)