Biofilm In ear discharge And Role Of Acetic Acid Vs Ciprofloxacin In Its Reduction

Magnitude Of Biofilm Burden In Active Mucosal Chronic Otitis Media And Role Of Acetic Acid Vs Ciprofloxacin In Its Reduction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/038387

Enrollment

100

Registered

2021-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H661- Chronic tubotympanic suppurative otitis media

Interventions

Intervention1: Acetic acid ear drops: Acetic acid ear drops (2% w/v) 3 drops TDS for 3 weeks Control Intervention1: Ciprofloxacin ear drops: Ciprofloxacin ear drops (0.3% w/v) 3 drops TDS for 3 wee

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between 18 to 65 years of age 2. Patients presenting with active chronic otitis media 3. Patients who are not on topical antibiotics treatment for 48 hours or more before sample collection. 4. Patients who are not on systemic antibiotics treatment for a minimum of 7 days before sample collection.

Exclusion criteria

Exclusion criteria: 1. Patients suffering from COM who are on systemic antibiotics in the past 7 days of presentation. 2. Patient suffering from squamosal type of chronic otitis media. 3. Patients having ear discharge due to otitis externa or traumatic or neoplastic condition. 4. Known diabetics, immunocompromised patients, or patients with Acute debilitating conditions. 5. Patients with evident fungal or mixed infection (bacterial with fungal) 6. Acute chronic otitis media with complications

Design outcomes

Primary

Measure	Time frame
To assess the prevalence of biofilm in active mucosal chronic otitis media cases in patients presenting in ENT OPD. 2. To assess the spectrum and antibiogram of bacteria in active mucosal chronic otitis media cases. Timepoint: 3 weeks	—

Secondary

Measure	Time frame
1. To assess the clinical response to acetic acid and compare it with ciprofloxacin in active mucosal chronic otitis media cases. 2. To determine correlation between clinical response and in vitro response to ciprofloxacin and acetic acid ear drops in active mucosal chronic otitis media cases. Timepoint: 3 weeks	—

Countries

India

Contacts

Public ContactAvinav Gupta

Maulana Azad Medical College and Associated Lok Nayak Hospital

drvikasmalhotra@hotmail.com8971051372

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026