Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

Karnataka Institute of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Adhesions of Nasal Cavity; Tissue Adhesions; Nasal Synechiae; Nasal Adhesions

Treatments: Drug: Mitomycin C; Device: Teflon nasal septal splint

Study type: Interventional

Funder types: Other

Identifiers

NCT00966056

01_M012_3210

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Mitomycin C

Active Comparator group

Description:

Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis

Treatment:

Drug: Mitomycin C

Teflon septal splint

Active Comparator group

Description:

Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis

Treatment:

Device: Teflon nasal septal splint