NCT00966056

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 8, 2011

Status Verified

August 1, 2009

Enrollment Period

1.3 years

First QC Date

August 25, 2009

Last Update Submit

July 7, 2011

Conditions

Nasal SynechiaeAdhesions of Nasal CavityNasal AdhesionsTissue Adhesions

Keywords

Nasal adhesionsNasal synechiaeMitomycinMitomycin cTeflonSplintsSeptal splints

Outcome Measures

Primary Outcomes (1)

  • Recurrence or absence of synechiae

    1 week, 1 month, 2 months

Secondary Outcomes (1)

  • Symptoms and complications

    1 week, 1 month, 2 months

Study Arms (2)

Mitomycin C

ACTIVE COMPARATOR

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

Drug: Mitomycin C

Teflon septal splint

ACTIVE COMPARATOR

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

Device: Teflon nasal septal splint

Interventions

Mitomycin CDRUG

Cotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15

Also known as: Mitomycin, Mitocin, MMC
Mitomycin C
Teflon nasal septal splintDEVICE

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

Also known as: Teflon splint, nasal septal splint, internal nasal splint
Teflon septal splint

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with nasal mucosal synechiae due to surgical or non-surgical trauma

You may not qualify if:

  • Patients with nasal vestibular stenosis
  • Patients with nasal synechiae due to diseases like Hansen's disease, Syphilis, Rhinoscleroma, Atrophic Rhinitis etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karnataka Institute of Medical Sciences

Hubli, Karnataka, 580022, India

Location

MeSH Terms

Conditions

Tissue Adhesions

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • VIKRAM K BHAT, MS(ENT), DNB

    Karnataka Institute of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

October 1, 2007

Primary Completion

February 1, 2009

Study Completion

September 1, 2009

Last Updated

July 8, 2011

Record last verified: 2009-08

Locations

IN(1)