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

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.

Keywords: COVID-19; Endoscopic staging; Mucormycosis.