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Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966056
First Posted: August 26, 2009
Last Update Posted: July 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Karnataka Institute of Medical Sciences
  Purpose
This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Karnataka Institute of Medical Sciences:

Primary Outcome Measures:
  • Recurrence or absence of synechiae [ Time Frame: 1 week, 1 month, 2 months ]

Secondary Outcome Measures:
  • Symptoms and complications [ Time Frame: 1 week, 1 month, 2 months ]

Enrollment: 60
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Teflon splint, nasal septal splint, internal nasal splint

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966056


Locations
India
Karnataka Institute of Medical Sciences
Hubli, Karnataka, India, 580022
Sponsors and Collaborators
Karnataka Institute of Medical Sciences
Investigators
Study Chair: VIKRAM K BHAT, MS(ENT), DNB Karnataka Institute of Medical Sciences
  More Information

Responsible Party: Dr SRINISH G, KARNATAKA INSTITUTE OF MEDICAL SCIENCES
ClinicalTrials.gov Identifier: NCT00966056     History of Changes
Other Study ID Numbers: 01_M012_3210
First Submitted: August 25, 2009
First Posted: August 26, 2009
Last Update Posted: July 8, 2011
Last Verified: August 2009

Keywords provided by Karnataka Institute of Medical Sciences:
Nasal adhesions
Nasal synechiae
Mitomycin
Mitomycin c
Teflon
Splints
Septal splints

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors