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

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.