Study designed to compare effect of pain once silastic sheet is placed over bare temporalis muscle after fascia over the muscle removed.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Patients with chronic otitis media
- Registration Number
- CTRI/2018/04/013422
- Lead Sponsor
- Karnataka institute of medical sciences Hubli
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Temporal pain-visual analogue scale <br/ ><br>2.Temporal tenderness-yes/no: type and duration. One inch vertically above surgical incision <br/ ><br>Timepoint: 3 MONTHS
- Secondary Outcome Measures
Name Time Method 1.Infection/abscess on surgical incision post operatively-Yes/No <br/ ><br>2.Nonhealing or gaping incision after 7 days-Present/Absent <br/ ><br>3.post op mastoid tenderness â?? <br/ ><br>3 finger test Yes/No <br/ ><br>4.Pain inside EAC and Middle ear deep pain â??Visual analogue scale <br/ ><br>5.Post op otitis externa-Pus with growth in C/S â??Yes/No <br/ ><br>Timepoint: 3 MONTHS