Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae
This study has been completed.
Sponsor:
Karnataka Institute of Medical Sciences
Information provided by:
Karnataka Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00966056
First received: August 25, 2009
Last updated: July 7, 2011
Last verified: August 2009
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Purpose
This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.
| Condition | Intervention | Phase |
|---|---|---|
|
Nasal Synechiae Adhesions of Nasal Cavity Nasal Adhesions Tissue Adhesions |
Drug: Mitomycin C Device: Teflon nasal septal splint |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae |
Resource links provided by NLM:
Further study details as provided by Karnataka Institute of Medical Sciences:
Primary Outcome Measures:
- Recurrence or absence of synechiae [ Time Frame: 1 week, 1 month, 2 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Symptoms and complications [ Time Frame: 1 week, 1 month, 2 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 60 |
| Study Start Date: | October 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mitomycin C
Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis
|
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
Other Name: Mitomycin, Mitocin, MMC
|
|
Active Comparator: Teflon septal splint
Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis
|
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
Other Name: Teflon splint, nasal septal splint, internal nasal splint
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966056
Locations
| India | |
| Karnataka Institute of Medical Sciences | |
| Hubli, Karnataka, India, 580022 | |
Sponsors and Collaborators
Karnataka Institute of Medical Sciences
Investigators
| Study Chair: | VIKRAM K BHAT, MS(ENT), DNB | Karnataka Institute of Medical Sciences |
More Information
No publications provided
| Responsible Party: | Dr SRINISH G, KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
| ClinicalTrials.gov Identifier: | NCT00966056 History of Changes |
| Other Study ID Numbers: | 01_M012_3210 |
| Study First Received: | August 25, 2009 |
| Last Updated: | July 7, 2011 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Karnataka Institute of Medical Sciences:
|
Nasal adhesions Nasal synechiae Mitomycin Mitomycin c |
Teflon Splints Septal splints |
Additional relevant MeSH terms:
|
Tissue Adhesions Cicatrix Fibrosis Pathologic Processes Mitomycins Mitomycin Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents |
ClinicalTrials.gov processed this record on May 23, 2013