How Silastic Sheets Help in Middle Ear Surgery: Better Healing and Improved Hearing

Outcomes of Surgical Management of Chronic Otitis Media with Silastic Sheet Graft Reinforcement - A Randomised Controlled Trial. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081932

Enrollment

Registered

2025-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: H720- Central perforation of tympanic membrane

Interventions

Intervention1: Silastic sheet ( decisheet silicone sheet ) insertion in middle ear surgeries: Group A :Silastic sheet of appropriate size would be placed in the medial wall of tympanic cavity during m

Eligibility

Inclusion criteria

Inclusion criteria: -Patients suffering from chronic otitis media -Patients who offered informed and written consent to undergo the surgical procedure

Exclusion criteria

Exclusion criteria: -Presence of middle ear mucosal edema -Presence of ossicular necrosis -Cholesteatoma -Granulation tissue tympanosclerosis and -Poor eustachian tube function.

Design outcomes

Primary

Measure	Time frame
1. Hearing outcome 2. Graft uptakeTimepoint: 1. 1 month, 2 months 2. 1 month, 2 months	—

Secondary

Measure	Time frame
At the end of follow-up period, to assess any complications like purulent ear dischargeTimepoint: One and two months post operatively to assess any complications that could arise	—

Countries

India

Contacts

Public ContactSharika Sakunthala A

Srm medical college hospital and research centre

malarvir@srmist.edu.in9444753019

Outcome results

None listed

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