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Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

This study has been completed.
Sponsor:
Information provided by:
Karnataka Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00966056
First received: August 25, 2009
Last updated: July 7, 2011
Last verified: August 2009
History of Changes

August 25, 2009
July 7, 2011
October 2007
February 2009   (final data collection date for primary outcome measure)
Recurrence or absence of synechiae [ Time Frame: 1 week, 1 month, 2 months ] [ Designated as safety issue: No ]
RRecurrence or absence of synechiae [ Time Frame: 1 week, 1 month, 2 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00966056 on ClinicalTrials.gov Archive Site
Symptoms and complications [ Time Frame: 1 week, 1 month, 2 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Nasal Synechiae
  • Adhesions of Nasal Cavity
  • Nasal Adhesions
  • Tissue Adhesions
  • 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 Name: 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 Name: Teflon splint, nasal septal splint, internal nasal splint
  • Active Comparator: Mitomycin C
    Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis
    Intervention: Drug: Mitomycin C
  • Active Comparator: Teflon septal splint
    Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis
    Intervention: Device: Teflon nasal septal splint
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00966056
01_M012_3210
Yes
Dr SRINISH G, KARNATAKA INSTITUTE OF MEDICAL SCIENCES
Karnataka Institute of Medical Sciences
Not Provided
Study Chair: VIKRAM K BHAT, MS(ENT), DNB Karnataka Institute of Medical Sciences
Karnataka Institute of Medical Sciences
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP