search
Back to results

Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

Primary Purpose

Nasal Synechiae, Adhesions of Nasal Cavity, Nasal Adhesions

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Mitomycin C
Teflon nasal septal splint
Sponsored by
Karnataka Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Synechiae focused on measuring Nasal adhesions, Nasal synechiae, Mitomycin, Mitomycin c, Teflon, Splints, Septal splints

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Karnataka Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mitomycin C

Teflon septal splint

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrence or absence of synechiae

Secondary Outcome Measures

Symptoms and complications

Full Information

First Posted
August 25, 2009
Last Updated
July 7, 2011
Sponsor
Karnataka Institute of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00966056
Brief Title
Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae
Official Title
Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karnataka Institute of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Synechiae, Adhesions of Nasal Cavity, Nasal Adhesions, Tissue Adhesions
Keywords
Nasal adhesions, Nasal synechiae, Mitomycin, Mitomycin c, Teflon, Splints, Septal splints

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mitomycin C
Arm Type
Active Comparator
Arm Description
Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis
Arm Title
Teflon septal splint
Arm Type
Active Comparator
Arm Description
Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Other Intervention Name(s)
Mitomycin, Mitocin, MMC
Intervention Description
Cotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15
Intervention Type
Device
Intervention Name(s)
Teflon nasal septal splint
Other Intervention Name(s)
Teflon splint, nasal septal splint, internal nasal splint
Intervention Description
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
Primary Outcome Measure Information:
Title
Recurrence or absence of synechiae
Time Frame
1 week, 1 month, 2 months
Secondary Outcome Measure Information:
Title
Symptoms and complications
Time Frame
1 week, 1 month, 2 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VIKRAM K BHAT, MS(ENT), DNB
Organizational Affiliation
Karnataka Institute of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Karnataka Institute of Medical Sciences
City
Hubli
State/Province
Karnataka
ZIP/Postal Code
580022
Country
India

12. IPD Sharing Statement

Learn more about this trial

Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

We'll reach out to this number within 24 hrs