To evaluate the efficacy of topical anti-fungal therapy in postoperative cases of COVID Associated Mucormycosis (CAM): A single-blinded randomized control trial.
Am J Otolaryngol
; 44(2): 103702, 2023.
Article
in English
| MEDLINE | ID: covidwho-2245096
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. STUDYDESIGN:
Multi-arm, parallel randomized control trial. STUDYSETTING:
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, povidoneiodine 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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19
/
Mucormycosis
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Am J Otolaryngol
Year:
2023
Document Type:
Article
Affiliation country:
J.amjoto.2022.103702
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