Nasal SynechiaePhase 2NCT00966056
Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae
A Phase 2 study testing Mitomycin C and Teflon nasal septal splint in people with Nasal Synechiae and Adhesions of Nasal Cavity, run by Karnataka Institute of Medical Sciences at 1 site in India.
Trial summary
This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nasal Synechiae, Adhesions of Nasal Cavity, Nasal Adhesions
- What is being tested?
- Mitomycin C and Teflon nasal septal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2007to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with nasal mucosal synechiae due to surgical or non-surgical trauma
Who cannot join
- Patients with nasal vestibular stenosis
- Patients with nasal synechiae due to diseases like Hansen's disease, Syphilis, Rhinoscleroma, Atrophic Rhinitis etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae
This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.
Read the 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.
- Being tested
- Mitomycin C, Teflon nasal septal splint
- Keywords
- Nasal adhesions, Nasal synechiae, Mitomycin, Mitomycin c, Teflon, Splints, Septal splints
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin CDrug
Also called Mitomycin, Mitocin, MMC
Cotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15
Teflon nasal septal splintDevice
Also called Teflon splint, nasal septal splint, internal nasal 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
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin C | Active comparator | Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis Receives: Drug: Mitomycin C |
| Teflon septal splint | Active comparator | Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis Receives: Device: Teflon nasal septal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence or absence of synechiae
Measured: 1 week, 1 month, 2 months
Secondary outcomes (1)
Symptoms and complications
Measured: 1 week, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startOct 2007
- Primary completionFeb 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal SynechiaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karnataka Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- VIKRAM K BHAT, MS(ENT), DNB, Study chair, Karnataka Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966056
- Sponsor's protocol ID
- 01_M012_3210
- Status last verified
- Aug 2009
- First submitted
- 25 Aug 2009
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae
- ClinicalTrials.gov ID
- NCT00966056
- Acronym / sponsor ID
- 01_M012_3210
- Keywords
- Nasal adhesions, Nasal synechiae, Mitomycin, Mitomycin c, Teflon, Splints, Septal splints
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karnataka Institute of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitomycin C | Active comparator | Drug: Mitomycin CCases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis |
| Teflon septal splint | Active comparator | Device: Teflon nasal septal splintCases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with nasal mucosal synechiae due to surgical or non-surgical trauma
Key exclusion criteria (2 listed)
- Patients with nasal vestibular stenosis
- Patients with nasal synechiae due to diseases like Hansen's disease, Syphilis, Rhinoscleroma, Atrophic Rhinitis etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin CAlso: Mitomycin, Mitocin, MMCCotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15 | Drug | Mitomycin C |
| Teflon nasal septal splintAlso: Teflon splint, nasal septal splint, internal nasal splintTeflon 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 | Device | Teflon septal splint |
Primary outcome
Recurrence or absence of synechiae
Time frame: 1 week, 1 month, 2 months
1 secondary outcome
Symptoms and complications
Time frame: 1 week, 1 month, 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VIKRAM K BHAT, MS(ENT), DNB study chair
Karnataka Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitomycin C and Teflon nasal septal splint in people with Nasal Synechiae and Adhesions of Nasal Cavity, run by Karnataka Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence or absence of synechiae (time frame: 1 week, 1 month, 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.