To evaluate the efficacy of topical anti-fungal therapy in postoperative cases of COVID Associated Mucormycosis (CAM) : A single-blinded randomized control trial
Copyright © 2022 Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:44 |
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| Enthalten in: |
American journal of otolaryngology - 44(2023), 2 vom: 15. März, Seite 103702 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shaikh, Zaid [VerfasserIn] |
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| Links: |
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| Themen: |
7XU7A7DROE |
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| Anmerkungen: |
Date Completed 22.03.2023 Date Revised 22.03.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.amjoto.2022.103702 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Shaikh, Zaid |e verfasserin |4 aut | |
| 245 | 1 | 3 | |a To evaluate the efficacy of topical anti-fungal therapy in postoperative cases of COVID Associated Mucormycosis (CAM) |b A single-blinded randomized control trial |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 22.03.2023 | ||
| 500 | |a Date Revised 22.03.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 Elsevier Inc. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a STUDY DESIGN: Multi-arm, parallel randomized control trial | ||
| 520 | |a STUDY SETTING: The trial was conducted in the Department of ENT, All India Institute of Medical Sciences (AIIMS) Bhubaneswar | ||
| 520 | |a METHODS: Participants: Microbiologically and histologically proven cases of mucormycosis who underwent surgical debridement were included in the study | ||
| 520 | |a 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 | ||
| 520 | |a OUTCOME: Requirement of revision surgery in postoperative cases of CAM | ||
| 520 | |a RANDOMIZATION: Participants were allotted to one of the three arms by block randomization | ||
| 520 | |a BLINDING: Single-blinded trial | ||
| 520 | |a RESULTS: Numbers randomized: 15 participants were randomized to each group. Recruitment: Completed recruiting. Numbers analyzed: 15 participants were analyzed in each group | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSIONS: Topical Amphotericin-B gel application in the postoperative cavity can decrease the need for revision surgery and help in early recovery | ||
| 520 | |a TRIAL REGISTRATION: CTRI/2021/10/037257. Clinical Trials Registry of India | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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