Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

Phase 2

Completed

• Conditions: Nasal Synechiae; Adhesions of Nasal Cavity; Nasal Adhesions; Tissue Adhesions
• Interventions: Device: Teflon nasal septal splint; Drug: Mitomycin C

• Registration Number: NCT00966056
• Lead Sponsor: Karnataka Institute of Medical Sciences

Brief Summary

This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2009-02
• Status Verified: 2009-08
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Study Completion: 2009-09
• Last Update Submitted: 2011-07-07
• Last Update Posted: 2011-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teflon septal splint	Teflon nasal septal splint	Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis
Mitomycin C	Mitomycin C	Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis

Primary Outcome Measures

Name	Time	Method
Recurrence or absence of synechiae	1 week, 1 month, 2 months

Secondary Outcome Measures

Name	Time	Method
Symptoms and complications	1 week, 1 month, 2 months

Trial Locations

Locations (1)

Karnataka Institute of Medical Sciences; 🇮🇳 Hubli, Karnataka, India