Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

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

Detailed Description
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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.

Official Title
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Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae

Conditions
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Nasal Synechiae, Adhesions of Nasal Cavity, Nasal Adhesions, Tissue Adhesions

Intervention / Treatment
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* Drug: Mitomycin C
* Device: Teflon nasal septal splint


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mitomycin C<br>Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis | Drug: Mitomycin C<br>* Cotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15<br>* Other names: Mitomycin, Mitocin, MMC;|
| Active Comparator: Teflon septal splint<br>Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis | Device: Teflon nasal septal splint<br>* Teflon internal nasal septal splint placed between the raw surfaces and secured at the anterior end of septum with catgut 3-0 sutures, following synechiolysis with surgical blade no.15. Splint removed at the end of one week<br>* Other names: Teflon splint, nasal septal splint, internal nasal splint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence or absence of synechiae |  | 1 week, 1 month, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and complications |  | 1 week, 1 month, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal adhesions, Nasal synechiae, Mitomycin, Mitomycin c, Teflon, Splints, Septal splints