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Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00966056
Enrollment
60
Registered
2009-08-26
Start date
2007-10-31
Completion date
2009-09-30
Last updated
2011-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesions of Nasal Cavity, Nasal Adhesions, Nasal Synechiae, Tissue Adhesions

Keywords

Nasal adhesions, Nasal synechiae, Mitomycin, Mitomycin c, Teflon, Splints, Septal splints

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.

Interventions

DRUGMitomycin 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

DEVICETeflon 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

Sponsors

Karnataka Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Recurrence or absence of synechiae1 week, 1 month, 2 months

Secondary

MeasureTime frame
Symptoms and complications1 week, 1 month, 2 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026