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Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

Information source: Karnataka Institute of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasal Synechiae; Adhesions of Nasal Cavity; Nasal Adhesions; Tissue Adhesions

Intervention: Mitomycin C (Drug); Teflon nasal septal splint (Device)

Phase: Phase 2

Status: Completed

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

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: Recurrence 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

Karnataka Institute of Medical Sciences, Hubli, Karnataka 580022, India
Additional Information

Starting date: October 2007
Last updated: July 7, 2011

Page last updated: August 23, 2015

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