Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-09-30

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.

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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.

Conditions

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Nasal Synechiae Adhesions of Nasal Cavity Nasal Adhesions Tissue Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mitomycin C

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

Group Type ACTIVE_COMPARATOR

Mitomycin C

Intervention Type DRUG

Cotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15

Teflon septal splint

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

Group Type ACTIVE_COMPARATOR

Teflon nasal septal splint

Intervention Type DEVICE

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

Interventions

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Mitomycin C

Cotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15

Intervention Type DRUG

Teflon nasal septal splint

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

Intervention Type DEVICE

Other Intervention Names

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Mitomycin, Mitocin, MMC Teflon splint, nasal septal splint, internal nasal splint

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes