Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae
Information source: Karnataka Institute of Medical Sciences
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasal Synechiae; Nasal Adhesions; Tissue Adhesions
Intervention: Mitomycin C (Drug); Teflon nasal septal splint (Device)
Phase: Phase 2
Status: Recruiting
Sponsored by: Karnataka Institute of Medical Sciences Official(s) and/or principal investigator(s):
VIKRAM K BHAT, MS(ENT), DNB, Study Chair, Affiliation: Karnataka Institute of Medical Sciences
Overall contact:
SRINISH G, MS(ENT), Phone: +919886080337, Email: dr_srinishg@rediffmail.com
Summary
This study evaluates whether Mitomycin C is an effective alternative to septal splints in
the treatment of nasal synechiae.
Clinical Details
Official title: Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: RRecurrence or absence of synechiae
Secondary outcome: Symptoms and complications
Detailed description:
Nasal synechiae is an important cause for the failure of many a nasal surgery. Septal
splints have been widely used for the treatment of nasal synechiae, but are associated
significant morbidity until removal. To the best of our knowledge there are no studies in
literature comparing Mitomycin C with septal splints as an atraumatic alternative in the
treatment of nasal synechiae. This is a preliminary study taken up to evaluate the
therapeutic efficacy of Mitomycin C in the treatment of nasal synechiae.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with nasal mucosal synechiae due to surgical or non-surgical trauma
Exclusion Criteria:
- Patients with nasal vestibular stenosis
- Patients with nasal synechiae due to diseases like Hansen's disease, Syphilis,
Rhinoscleroma, Atrophic Rhinitis etc.
Locations and Contacts
SRINISH G, MS(ENT), Phone: +919886080337, Email: dr_srinishg@rediffmail.com
Karnataka Institute of Medical Sciences, Hubli, Karnataka 580022, India; Recruiting
UMESH S NAGALOTIMATH, MS(ENT), DNB, Phone: +919449864827, Email: umesh_nagalotimath@yahoo.com
SRINISH G, MS(ENT), Principal Investigator
Additional Information
Starting date: October 2007
Last updated: August 25, 2009
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