Trial | NCT00966056  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mitomycin ...

  • Study Participants

    60
This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.
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 Started
Oct 31
2007
Primary Completion
Feb 28
2009
Study Completion
Sep 30
2009
Last Update
Jul 08
2011
Estimate

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

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

Mitomycin C Active Comparator

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

Teflon septal splint Active Comparator

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

Criteria 

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.
No Results Posted