Chronic RhinosinusitisNCT05083741
Comparison of Chitodex Gel Vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis
An observational study of Chronic Rhinosinusitis, run by St. Louis University at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Chitogel and Nexfoam
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2021to 8 Aug 2024
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SLUCare Otolaryngology Clinic
Who may be able to join
- Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
- ≥ 18 years to ≤ 90 years AND
- English speaking AND
- Able to give written informed consent AND
- Local residents who will be returning to this center for postoperative follow-up care AND
- Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 \& 12 (± 2) weeks post-op.
Who cannot join
- allergy to shellfish
- pregnant or breastfeeding
- Hepatitis or blood disorders
- any drug allergy
- allergy to potato starch (due to Nexfoam)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Head to Head Comparison of Chitodex Gel with Triamcinolone Vs NexFoam with Triamcinalone on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis (CRS)
The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.
Read the detailed description
The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Chitogel, Nexfoam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitogelDevice
post-operative dressing within standard of care
NexfoamDevice
post-operative dressing within standard of care
| Study group | Role | What they receive |
|---|---|---|
| Chitogel | Chitodex gel plus Kenalog inserted into the middle meatus Receives: Device: Chitogel | |
| Nexfoam | NexFoam plus Kenalog inserted into the middle meatus Receives: Device: Nexfoam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Scores on Endoscopy
Outcome measured based on the wound healing in the sinus openings made during surgery.
Measured: 12 (±2) weeks post surgery
Secondary outcomes (1)
Symptom Scores on Patients' Self-Directed Questionnaires
Outcomes measured based on patients' personal symptom assessment.
Measured: 12 (±2) weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start27 Dec 2021
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Why it stopped: lack of recruitment and usable data
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 Chronic RhinosinusitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Brunworth, MD, St. Louis University
- Investigators
- Joseph D Brunworth, MD, Principal investigator, Department of Otolaryngology-Head & Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083741
- Sponsor's protocol ID
- 31454
- Status last verified
- Aug 2024
- First submitted
- 6 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ngoc Ha T, Valentine R, Moratti S, Robinson S, Hanton L, Wormald PJ. A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jul;3(7):573-80. doi: 10.1002/alr.21136. Epub 2013 Jan 16.
PubMed 23322408Le T, Psaltis A, Tan LW, Wormald PJ. The efficacy of topical antibiofilm agents in a sheep model of rhinosinusitis. Am J Rhinol. 2008 Nov-Dec;22(6):560-7. doi: 10.2500/ajr.2008.22.3232.
PubMed 19178792Jervis-Bardy J, Boase S, Psaltis A, Foreman A, Wormald PJ. A randomized trial of mupirocin sinonasal rinses versus saline in surgically recalcitrant staphylococcal chronic rhinosinusitis. Laryngoscope. 2012 Oct;122(10):2148-53. doi: 10.1002/lary.23486. Epub 2012 Aug 2.
PubMed 22865576
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head to Head Comparison of Chitodex Gel with Triamcinolone Vs NexFoam with Triamcinalone on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis (CRS)
- ClinicalTrials.gov ID
- NCT05083741
- Acronym / sponsor ID
- 31454
- Conditions
- Chronic Rhinosinusitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of recruitment and usable data
- Enrolment
- 7 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 19 Oct 2021 (actual)
- 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.
The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.
Detailed description
The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chitogel | – | Device: ChitogelChitodex gel plus Kenalog inserted into the middle meatus |
| Nexfoam | – | Device: NexfoamNexFoam plus Kenalog inserted into the middle meatus |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SLUCare Otolaryngology Clinic
Key inclusion criteria (6 listed)
- Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
- ≥ 18 years to ≤ 90 years AND
- English speaking AND
- Able to give written informed consent AND
- Local residents who will be returning to this center for postoperative follow-up care AND
Key exclusion criteria (5 listed)
- allergy to shellfish
- pregnant or breastfeeding
- Hepatitis or blood disorders
- any drug allergy
- allergy to potato starch (due to Nexfoam)
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 |
|---|---|---|
| Chitogelpost-operative dressing within standard of care | Device | Chitogel |
| Nexfoampost-operative dressing within standard of care | Device | Nexfoam |
Primary outcome
Clinical Scores on Endoscopy
Time frame: 12 (±2) weeks post surgery
Outcome measured based on the wound healing in the sinus openings made during surgery.
1 secondary outcome
Symptom Scores on Patients' Self-Directed Questionnaires
Time frame: 12 (±2) weeks post surgery
Results and safety
The study was stopped early (reason given: lack of recruitment and usable data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 23322408Ngoc Ha T, Valentine R, Moratti S, Robinson S, Hanton L, Wormald PJ. A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jul;3(7):573-80. doi: 10.1002/alr.21136. Epub 2013 Jan 16.
- Background: PubMed 19178792Le T, Psaltis A, Tan LW, Wormald PJ. The efficacy of topical antibiofilm agents in a sheep model of rhinosinusitis. Am J Rhinol. 2008 Nov-Dec;22(6):560-7. doi: 10.2500/ajr.2008.22.3232.
- Background: PubMed 22865576Jervis-Bardy J, Boase S, Psaltis A, Foreman A, Wormald PJ. A randomized trial of mupirocin sinonasal rinses versus saline in surgically recalcitrant staphylococcal chronic rhinosinusitis. Laryngoscope. 2012 Oct;122(10):2148-53. doi: 10.1002/lary.23486. Epub 2012 Aug 2.
- Individual participant dataSharing planned: Undecided
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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.
Joseph D Brunworth, MD principal investigator
Department of Otolaryngology-Head & Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis, run by St. Louis University at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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 United States. 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 was stopped early (reason given: lack of recruitment and usable data). Results are not available in the source record.
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?
Clinical Scores on Endoscopy (time frame: 12 (±2) weeks post surgery). 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 NCT05083741, 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 19 Sep 2024.