Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae - Full Text View

Sponsor:	Karnataka Institute of Medical Sciences
Information provided by:	Karnataka Institute of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00966056

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Adhesions

Drug Information available for: Mitomycin Mitomycins Polytetrafluoroethylene

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptoms and complications [ Time Frame: 1 week, 1 month, 2 months ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Dr SRINISH G, KARNATAKA INSTITUTE OF MEDICAL SCIENCES
ClinicalTrials.gov Identifier:	NCT00966056 History of Changes
Other Study ID Numbers:	01_M012_3210
Study First Received:	August 25, 2009
Last Updated:	July 7, 2011
Health Authority:	India: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on February 09, 2012