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Completed

NCT Number: NCT00966056

Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

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

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Key information

Conditions

Nasal Synechiae Adhesions of Nasal Cavity Cicatrix Fibrosis Nasal Adhesions Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karnataka Institute of Medical Sciences

Hubli, Karnataka, 580022, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mitomycin C

Drug

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

Teflon nasal septal splint

Device

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

Primary outcomes

  1. Recurrence or absence of synechiae

    Time frame: 1 week, 1 month, 2 months

Secondary outcomes

  1. Symptoms and complications

    Time frame: 1 week, 1 month, 2 months

Sponsors and collaborators

Lead sponsor

Karnataka Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 26, 2009
Registry last updated
Jul 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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