Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

July 7, 2011 updated by: Karnataka Institute of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Hubli, Karnataka, India, 580022
        • Karnataka Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence or absence of synechiae
Time Frame: 1 week, 1 month, 2 months
1 week, 1 month, 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms and complications
Time Frame: 1 week, 1 month, 2 months
1 week, 1 month, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karnataka Institute of Medical Sciences

Investigators

  • Study Chair: VIKRAM K BHAT, MS(ENT), DNB, Karnataka Institute of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

July 8, 2011

Last Update Submitted That Met QC Criteria

July 7, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01_M012_3210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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