SinusitisSYNECHIAENCT02077322
Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery
A study testing Silastic Spacer and Merocel Spacer in people with Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Silastic Spacer and Merocel Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to May 2017
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 19 years, currently receiving sinus-related care at the St Paul's Sinus Centre for chronic rhinosinusitis and who undergo primary bilateral complete endoscopic sinus surgery will be approached to participate in this clinical trial.
Who cannot join
- Patients with sino-nasal tumors
- Patients solely undergoing nasal septal reconstruction
- Patients with previous history of endoscopic sinus surgery
- Cystic fibrosis or syndromic patients
- Patients with autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Paul's Hospital Sinus Centre
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial Comparing Gloved Merocel and Silastic Middle Meatal Spacers.
Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.
- Conditions
- Sinusitis
- Being tested
- Silastic Spacer, Merocel Spacer
- Keywords
- Merocel Middle Meatus Spacers, Silastic Middle Meatus Spacers, Functional Endoscopic Sinus Surgery
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silastic SpacerDevice
Also called Experimental Arm
The Silastic spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.
Merocel SpacerDevice
Also called Control Arm
The Merocel spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Silastic Spacer | Experimental | This study arm receives the experimental treatment, a Silastic spacer. Receives: Device: Silastic Spacer |
| Merocel Spacer | Active comparator | Merocel spacers are actively being used as the standard of care. Receives: Device: Merocel Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported.
Incidence of postoperative synechiae will be compared between right and left nasal cavities receiving either silastic or glove finger spacers.
Measured: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Secondary outcomes (1)
Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported.
Secondary comparisons of postoperative synechiae will be compared between subjects in the 6-day vs 14-day spacer removal groups.
Measured: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Javer, St. Paul's Hospital, Canada
- Investigators
- Amin R Javer, MD, FRCSC, FARS, Principal investigator, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077322
- Sponsor's protocol ID
- Synechiae-2014
- Acronym
- SYNECHIAE
- Status last verified
- Apr 2018
- First submitted
- 27 Feb 2014
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller RS, Steward DL, Tami TA, Sillars MJ, Seiden AM, Shete M, Paskowski C, Welge J. The clinical effects of hyaluronic acid ester nasal dressing (Merogel) on intranasal wound healing after functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2003 Jun;128(6):862-9. doi: 10.1016/S0194-59980300460-1.
PubMed 12825038Catalano PJ, Roffman EJ. Evaluation of middle meatal stenting after minimally invasive sinus techniques (MIST). Otolaryngol Head Neck Surg. 2003 Jun;128(6):875-81. doi: 10.1016/S0194-59980300469-8.
PubMed 12825040Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy Rhinol. 2012 Nov;2(6):477-86. doi: 10.1002/alr.21052. Epub 2012 May 30.
PubMed 22648984
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial Comparing Gloved Merocel and Silastic Middle Meatal Spacers.
- ClinicalTrials.gov ID
- NCT02077322
- Acronym / sponsor ID
- SYNECHIAE / Synechiae-2014
- Conditions
- Sinusitis
- Keywords
- Merocel Middle Meatus Spacers, Silastic Middle Meatus Spacers, Functional Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Mar 2014 (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.
Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silastic Spacer | Experimental | Device: Silastic SpacerThis study arm receives the experimental treatment, a Silastic spacer. |
| Merocel Spacer | Active comparator | Device: Merocel SpacerMerocel spacers are actively being used as the standard of care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 19 years, currently receiving sinus-related care at the St Paul's Sinus Centre for chronic rhinosinusitis and who undergo primary bilateral complete endoscopic sinus surgery will be approached to participate in this clinical trial.
Key exclusion criteria (5 listed)
- Patients with sino-nasal tumors
- Patients solely undergoing nasal septal reconstruction
- Patients with previous history of endoscopic sinus surgery
- Cystic fibrosis or syndromic patients
- Patients with autoimmune diseases
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 |
|---|---|---|
| Silastic SpacerAlso: Experimental ArmThe Silastic spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery. | Device | Silastic Spacer |
| Merocel SpacerAlso: Control ArmThe Merocel spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery. | Device | Merocel Spacer |
Primary outcome
Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported. Incidence of postoperative synechiae will be compared between right and left nasal cavities receiving either silastic or glove finger spacers.
1 secondary outcome
Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
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 20 Apr 2018.
- Background: PubMed 12825038Miller RS, Steward DL, Tami TA, Sillars MJ, Seiden AM, Shete M, Paskowski C, Welge J. The clinical effects of hyaluronic acid ester nasal dressing (Merogel) on intranasal wound healing after functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2003 Jun;128(6):862-9. doi: 10.1016/S0194-59980300460-1.
- Background: PubMed 12825040Catalano PJ, Roffman EJ. Evaluation of middle meatal stenting after minimally invasive sinus techniques (MIST). Otolaryngol Head Neck Surg. 2003 Jun;128(6):875-81. doi: 10.1016/S0194-59980300469-8.
- Background: PubMed 22648984Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy Rhinol. 2012 Nov;2(6):477-86. doi: 10.1002/alr.21052. Epub 2012 May 30.
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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.
Amin R Javer, MD, FRCSC, FARS principal investigator
St. Paul's Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silastic Spacer and Merocel Spacer in people with Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
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 5 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 20 Apr 2018. 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 Canada. 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.
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?
Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups. (time frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02077322, which also lists 3 linked publications.
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 20 Apr 2018.