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Study designed to compare effect of pain once silastic sheet is placed over bare temporalis muscle after fascia over the muscle removed.

A study of the prevention and Management of pain and tenderness induced by temporalis fascia harvesting.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013422
Enrollment
120
Registered
2018-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients with chronic otitis media

Interventions

Intervention1: Patients with silastic sheet: Application of silastic sheet after harvesting temporalis fascia over bare temporalis muscle in half of sample size. Control Intervention1: Patients withou

Sponsors

Karnataka institute of medical sciences Hubli
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Both layers of temporalis fascia harvested. 2)Temporalis muscle exposed to subcutaneous tissue after harvesting. 3)Tympanoplasty/ ossiculoplasty/canal wall up procedure or mastoidotympanoplasty 4)Age group; 18 to 60 years

Exclusion criteria

Exclusion criteria: 1)Mastoiditis and mastoid/temporal abscesses 2)Fascia not harvested 3)Revision surgeries 4)Only true or false fascia harvested 5)Ipsilateral temporal pain and tenderness before surgery 6)Allodynia 7)Immunocompromised-HIV positive 8)Diabetic patients 9)HbsAg positive 10)Migraine or temporal arteritis or tension headache 11)Canal wall down mastoidotympanoplasty 12)Use of cautery for harvesting graft

Design outcomes

Primary

MeasureTime frame
1.Temporal pain-visual analogue scale 2.Temporal tenderness-yes/no: type and duration. One inch vertically above surgical incision Timepoint: 3 MONTHS—

Secondary

MeasureTime frame
1.Infection/abscess on surgical incision post operatively-Yes/No 2.Nonhealing or gaping incision after 7 days- Present/Absent 3.post op mastoid tenderness â?? 3 finger test Yes/No 4.Pain inside EAC and Middle ear deep pain â??Visual analogue scale 5.Post op otitis externa-Pus with growth in C/S â??Yes/No Timepoint: 3 MONTHS—

Countries

India

Contacts

Public ContactShivashankar Ajur

Karnataka institute of medical sciences

vikram.ent@gmail.com7899610213

Outcome results

None listed

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