Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

Tissue Adhesions Clinical Trial

Official title:

Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966056
• Other study ID #: 01_M012_3210
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2009
• Last updated: July 7, 2011
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: August 2009
• Source: Karnataka Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesions of Nasal Cavity
• Nasal Adhesions
• Nasal Synechiae
• Tissue Adhesions

Intervention

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

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

Locations

Country	Name	City	State
India	Karnataka Institute of Medical Sciences	Hubli	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Karnataka Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence or absence of synechiae		1 week, 1 month, 2 months	No
Secondary	Symptoms and complications		1 week, 1 month, 2 months	Yes