SinusitisPhase 4FISHNETNCT01420471
Medicated Punctured-Glove-Finger Spacer Study
A Phase 4 study testing Triamcinolone and Saline-impregnated spacer in people with Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy the inclusion/exclusion criteria will be included in the study. All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati 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?
- Triamcinolone and Saline-impregnated spacer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Jun 2012
- Phase
- Phase 4
- 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
- All CRS patients undergoing bilateral endoscopic surgery requiring spacers
Who cannot join
- Patients under the age of 19
- Patients unable to understand English
- Patients who are pregnant
- Patients with known bleeding disorders
- Patients with systemic disorders affecting the nose
- Patients in another concurrent study
Show all 10Show fewer
- Unilateral endoscopic sinus surgery
- Surgery in which spacers are not needed
- Patients undergoing sinonasal tumour resection
- Patients who cannot tolerate or are allergic to triamcinolone
Trial locations and contacts
1 site in 1 country.
Canada1 site
E.N.T. Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy the inclusion/exclusion criteria will be included in the study.
All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as their own controls. Nostril's will be randomized to either the experimental treatment (Triamcinolone-impregnated spacer) or the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op.
Read more
Participants will undergo the standard post-operative endoscopic sinus surgery follow-up appointments plus one additional research visit (not standard of care). This includes follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the post-operative period. During these appointments, the surgeon will assess the post-operative mucosal appearance (Philpott-Javer Sinus Rating System). SNOT-22 surveys will be administered, as per standard protocol, at each post-op follow up visit.
Sinus tissue biopsies will be taken from both meati on 28-day and 3-month post-op follow-up appointments for analysis.
Our objective is to determine if triamcinolone soaked Merocel middle meatus spacers (MMS) in a perforated glove finger improves patient outcomes, wound healing and reduces inflammation compared to a standard saline-soaked merocel sponge within a perforated glove finger in CRS patients receiving FESS.
Our hypothesis is that triamcinolone-medicated Merocel MMS are not inferior to standard saline-soaked spacers, when both are enclosed in a perforated surgical glove finger.
Read the detailed description
Patients suffering from chronic rhinosinusitis undergoing Functional Endoscopic Sinus Surgery (FESS) require nasal spacers to be inserted intra-operatively into the middle-meatus to prevent lateralization of the middle turbinate and subsequent scarring and adhesions. Nasal spacers can be impregnated with topical steroids to assist in post-surgical recovery. Our centre is now investigating the effect of triamcinolone-medicated nasal spacers placed inside a punctured glove finger to improve wound healing.
All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as their own controls. One nostril will receive the experimental treatment (Triamcinolone-impregnated spacer) and one will receive the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op.
Randomization of patients' nostrils to a treatment arm will occur on the day of surgery based on a closed envelope system.
Participants will undergo the standard post-operative endoscopic sinus surgery follow-up appointments plus one additional research visit (not standard of care). This includes follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the post-operative period. The 14-day follow-up appointment is an additional visit not included as standard practice at our centre. However, study patients will have this added visit in order to closely observe their recovery and endoscopic evaluation. During these appointments, the surgeon will assess the post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain, and 1st week post-operative bleeding (only at 6 day visit).
The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study participants at 6 days, 14 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a 5-minute questionnaire consisting of 22 questions, which asks participants to rate their sinus symptoms and social/emotional consequences of their nasal disorder from "no problem" to "problem as bad as it can be."
Sinus tissue biopsies will also be taken from both meati intraoperatively (standard of care) and on 28-day and 3-month post-op follow-up appointments (above standard of care). Biopsies will be sent to a pathologist for grading on a scale of tissue inflammation. To grade the level of mucosal inflammation in an objective fashion, the pathologist has previously devised a grading system on a scale from 0 to 4. A score of 0 is given for normal tissue, 1 for submucosal inflammation with no inflammatory infiltrate into the epithelium, 2 for inflammatory infiltrate with neutrophils into the epithelium with no evidence of necrosis, 3 for inflammatory infiltrate with neutrophils into the epithelium with evidence of focal necrosis and 4 for inflammatory infiltrate with neutrophils into the epithelium with evidence of extensive necrosis (5).
- Conditions
- Sinusitis
- Being tested
- Triamcinolone, Saline-impregnated spacer
- Keywords
- Endoscopic Sinus Surgery, Triamcinolone, Merocel Middle Meatus Spacers
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Also called Triamcinolone-impregnated Middle Meatus Spacer, Experimental treatment, Endoscopic Sinus Surgery
Spacer will be impregnated with 2mL of Triamcinolone. The triamcinolone-impregnated 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 days following surgery.
Saline-impregnated spacerOther
Also called Saline-impregnated middle meatal spacer, Endoscopic sinus surgery, Control
Spacer will be impregnated with 2mL of Saline solution. The saline-impregnated spacer will be inserted into the middle meatal space intraoperatively. The spacer will be left in the middle meatus for a period of 6 days following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Saline-impregnated spacer | Active comparator | Saline-impregnated spacers are actively being used as the standard of care. It does not contain any active ingredients. Receives: Other: Saline-impregnated spacer |
| Triamcinolone-impregnated spacer | Experimental | This study arm receives the experimental treatment, a Triamcinolone-impregnated spacer. Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative endoscopic appearance
Participants in the study have their sinus cavities assessed by rigid endoscopy and mucosa graded by the Lund-Kennedy and Philpott-Javer scaling system. Each sinus cavity (frontal, ethmoid, maxillary and sphenoid) and olfactory cleft will be given a score between zero and nine, with an extra point for the presence of fungal mucin, achieving a total potential maximum out of fifty per side (14).
Measured: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Post-operative inflammation
Participants will have biopsies taken from both middle meati in contact with nasal packing. Biopsies will be assessed and scored with a previously utilized histologic scoring system at our centre in order to determine the level of inflammation between the triamcinolone-medicated and saline-soaked spacers.
Measured: Biopsies will be removed during a 3 month period (beginning the day of surgery)
Secondary outcomes (1)
Post-Operative SNOT-22
Sino-Nasal Outcome Test (SNOT-22) is current standard in Rhinology for the assessment of the patient's subjective sinus symptoms and its effect on their daily functioning.
Measured: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT01420471
- Sponsor's protocol ID
- FISHNET-2011
- Acronym
- FISHNET
- Status last verified
- Oct 2012
- First submitted
- 18 Aug 2011
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Desrosiers M, Hussain A, Frenkiel S, Kilty S, Marsan J, Witterick I, Wright E. Intranasal corticosteroid use is associated with lower rates of bacterial recovery in chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2007 Apr;136(4):605-9. doi: 10.1016/j.otohns.2006.10.028.
PubMed 17418259Chang EH, Alandejani T, Akbari E, Ostry A, Javer A. Double-blinded, randomized, controlled trial of medicated versus nonmedicated merocel sponges for functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg. 2011 Feb;40 Suppl 1:S14-9.
PubMed 21453656Shoman N, Gheriani H, Flamer D, Javer A. Prospective, double-blind, randomized trial evaluating patient satisfaction, bleeding, and wound healing using biodegradable synthetic polyurethane foam (NasoPore) as a middle meatal spacer in functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg. 2009 Feb;38(1):112-8.
PubMed 19344620Franklin JH, Wright ED. Randomized, controlled, study of absorbable nasal packing on outcomes of surgical treatment of rhinosinusitis with polyposis. Am J Rhinol. 2007 Mar-Apr;21(2):214-7. doi: 10.2500/ajr.2007.21.3011.
PubMed 17424883
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicated Punctured-Glove-Finger Spacer Study
- ClinicalTrials.gov ID
- NCT01420471
- Acronym / sponsor ID
- FISHNET / FISHNET-2011
- Conditions
- Sinusitis
- Keywords
- Endoscopic Sinus Surgery, Triamcinolone, Merocel Middle Meatus Spacers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Aug 2011 (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.
All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy the inclusion/exclusion criteria will be included in the study.
All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as their own controls. Nostril's will be randomized to either the experimental treatment (Triamcinolone-impregnated spacer) or the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op.
Participants will undergo the standard post-operative endoscopic sinus surgery follow-up appointments plus one additional research visit (not standard of care). This includes follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the post-operative period. During these appointments, the surgeon will assess the post-operative mucosal appearance (Philpott-Javer Sinus Rating System). SNOT-22 surveys will be administered, as per standard protocol, at each post-op follow up visit.
Sinus tissue biopsies will be taken from both meati on 28-day and 3-month post-op follow-up appointments for analysis.
Our objective is to determine if triamcinolone soaked Merocel middle meatus spacers (MMS) in a perforated glove finger improves patient outcomes, wound healing and reduces inflammation compared to a standard saline-soaked merocel sponge within a perforated glove finger in CRS patients receiving FESS.
Our hypothesis is that triamcinolone-medicated Merocel MMS are not inferior to standard saline-soaked spacers, when both are enclosed in a perforated surgical glove finger.
Detailed description
Patients suffering from chronic rhinosinusitis undergoing Functional Endoscopic Sinus Surgery (FESS) require nasal spacers to be inserted intra-operatively into the middle-meatus to prevent lateralization of the middle turbinate and subsequent scarring and adhesions. Nasal spacers can be impregnated with topical steroids to assist in post-surgical recovery. Our centre is now investigating the effect of triamcinolone-medicated nasal spacers placed inside a punctured glove finger to improve wound healing.
All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as their own controls. One nostril will receive the experimental treatment (Triamcinolone-impregnated spacer) and one will receive the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op.
Randomization of patients' nostrils to a treatment arm will occur on the day of surgery based on a closed envelope system.
Participants will undergo the standard post-operative endoscopic sinus surgery follow-up appointments plus one additional research visit (not standard of care). This includes follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the post-operative period. The 14-day follow-up appointment is an additional visit not included as standard practice at our centre. However, study patients will have this added visit in order to closely observe their recovery and endoscopic evaluation. During these appointments, the surgeon will assess the post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain, and 1st week post-operative bleeding (only at 6 day visit).
The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study participants at 6 days, 14 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a 5-minute questionnaire consisting of 22 questions, which asks participants to rate their sinus symptoms and social/emotional consequences of their nasal disorder from "no problem" to "problem as bad as it can be."
Sinus tissue biopsies will also be taken from both meati intraoperatively (standard of care) and on 28-day and 3-month post-op follow-up appointments (above standard of care). Biopsies will be sent to a pathologist for grading on a scale of tissue inflammation. To grade the level of mucosal inflammation in an objective fashion, the pathologist has previously devised a grading system on a scale from 0 to 4. A score of 0 is given for normal tissue, 1 for submucosal inflammation with no inflammatory infiltrate into the epithelium, 2 for inflammatory infiltrate with neutrophils into the epithelium with no evidence of necrosis, 3 for inflammatory infiltrate with neutrophils into the epithelium with evidence of focal necrosis and 4 for inflammatory infiltrate with neutrophils into the epithelium with evidence of extensive necrosis (5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline-impregnated spacer | Active comparator | Other: Saline-impregnated spacerSaline-impregnated spacers are actively being used as the standard of care. It does not contain any active ingredients. |
| Triamcinolone-impregnated spacer | Experimental | Drug: TriamcinoloneThis study arm receives the experimental treatment, a Triamcinolone-impregnated spacer. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All CRS patients undergoing bilateral endoscopic surgery requiring spacers
Key exclusion criteria (10 listed)
- Patients under the age of 19
- Patients unable to understand English
- Patients who are pregnant
- Patients with known bleeding disorders
- Patients with systemic disorders affecting the nose
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 |
|---|---|---|
| TriamcinoloneAlso: Triamcinolone-impregnated Middle Meatus Spacer, Experimental treatment, Endoscopic Sinus SurgerySpacer will be impregnated with 2mL of Triamcinolone. The triamcinolone-impregnated 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 days following surgery. | Drug | Triamcinolone-impregnated spacer |
| Saline-impregnated spacerAlso: Saline-impregnated middle meatal spacer, Endoscopic sinus surgery, ControlSpacer will be impregnated with 2mL of Saline solution. The saline-impregnated spacer will be inserted into the middle meatal space intraoperatively. The spacer will be left in the middle meatus for a period of 6 days following surgery. | Other | Saline-impregnated spacer |
Primary outcome
Post-operative endoscopic appearance
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Participants in the study have their sinus cavities assessed by rigid endoscopy and mucosa graded by the Lund-Kennedy and Philpott-Javer scaling system. Each sinus cavity (frontal, ethmoid, maxillary and sphenoid) and olfactory cleft will be given a score between zero and nine, with an extra point for the presence of fungal mucin, achieving a total potential maximum out of fifty per side (14).
Post-operative inflammation
Time frame: Biopsies will be removed during a 3 month period (beginning the day of surgery)
Participants will have biopsies taken from both middle meati in contact with nasal packing. Biopsies will be assessed and scored with a previously utilized histologic scoring system at our centre in order to determine the level of inflammation between the triamcinolone-medicated and saline-soaked spacers.
1 secondary outcome
Post-Operative SNOT-22
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 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 30 Oct 2012.
- Background: PubMed 17418259Desrosiers M, Hussain A, Frenkiel S, Kilty S, Marsan J, Witterick I, Wright E. Intranasal corticosteroid use is associated with lower rates of bacterial recovery in chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2007 Apr;136(4):605-9. doi: 10.1016/j.otohns.2006.10.028.
- Results publication: PubMed 21453656Chang EH, Alandejani T, Akbari E, Ostry A, Javer A. Double-blinded, randomized, controlled trial of medicated versus nonmedicated merocel sponges for functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg. 2011 Feb;40 Suppl 1:S14-9.
- Results publication: PubMed 19344620Shoman N, Gheriani H, Flamer D, Javer A. Prospective, double-blind, randomized trial evaluating patient satisfaction, bleeding, and wound healing using biodegradable synthetic polyurethane foam (NasoPore) as a middle meatal spacer in functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg. 2009 Feb;38(1):112-8.
- Results publication: PubMed 17424883Franklin JH, Wright ED. Randomized, controlled, study of absorbable nasal packing on outcomes of surgical treatment of rhinosinusitis with polyposis. Am J Rhinol. 2007 Mar-Apr;21(2):214-7. doi: 10.2500/ajr.2007.21.3011.
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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 Phase 4 study testing Triamcinolone and Saline-impregnated 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 10 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 30 Oct 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Post-operative endoscopic appearance (time frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.). The study lists 2 primary outcomes in all. 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 NCT01420471, which also lists 4 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 30 Oct 2012.