Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

Sponsor

Karnataka Institute of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00966056

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nasal Synechiae Adhesions of Nasal Cavity Nasal Adhesions Tissue Adhesions	Drug: Mitomycin C Device: Teflon nasal septal splint	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mitomycin C Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis	Drug: 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 Other Names: Mitomycin, Mitocin, MMC
Active Comparator: Teflon septal splint Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis	Device: 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 Other Names: Teflon splint, nasal septal splint, internal nasal splint

Arm

Intervention/Treatment

Active Comparator: Mitomycin C

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

Drug: 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

Other Names:

Mitomycin, Mitocin, MMC

Active Comparator: Teflon septal splint

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

Device: 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

Other Names:

Teflon splint, nasal septal splint, internal nasal splint

Outcome Measures

Primary Outcome Measures

Recurrence or absence of synechiae [1 week, 1 month, 2 months]

Secondary Outcome Measures

Symptoms and complications [1 week, 1 month, 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.