Sinusitis, Frontal, Stent
Conditions
Keywords
Propel Stent, Nasopore
Brief summary
Surgery on the frontal sinus is done for patients who have sinus problems that do not respond to medications. It involves making an opening within the right and left frontal sinus of the nose to help it drain. For severe frontal sinus disease, the sinus is widely opened and the left and right sinuses become one large sinus. This is done with sharp instruments and rigid endoscopes placed through the nostrils. While the sinus heals after surgery, a stent or steroids or both may be used to try to help make sure that the opening does not close back up. Two current options for this are Propel stents and steroid-soaked Nasopore. Propel stents are FDA-approved. Nasopore and Kenalog injection are both FDA-approved, but their use together is part of the study and not specifically FDA-approved. A previous study shows that Propel stents are useful to reduce scarring in other frontal sinus procedures. We would like to know whether this is true in larger frontal sinus surgery where one common cavity is made and whether both steroid-containing stents are the same.
Detailed description
Endoscopic sinus surgery is commonly used to manage chronic inflammatory frontal sinus disease that is not adequately controlled with medical therapy alone. In recalcitrant cases, a more extensive procedure called the modified endoscopic Lothrop procedure or frontal drill-out (FDO) procedure is often performed. The frontal drill-out procedure is performed endoscopically and its goal is to create one large common cavity between the left and right frontal sinuses and nasal cavities to allow adequate drainage and communication for subsequent drug delivery through sinonasal irrigations if indicated. Failure of this procedure is most commonly the results of re-stenosis of the outflow tract due to scarring, adhesions, or progressive disease such as polyposis. One meta analysis assessing the long-term complications of frontal drillouts reported an overall failure rate to be 13.9%, defined as those individuals needing further surgery. Another clinical trial reported a failure rate for a 200-person study to be 30%. Placing a steroid-eluding biodegradable stent into the sinonasal cavities after surgery is thought to reduce the occurrence of re-stenosis, both by physically stenting the opening and by treating resultant inflammation with corticosteroid. Propel stents are made of synthetic dissolvable polymer that contains a corticosteroid (mometasone furoate) and has been FDA-approved to stent and reduce inflammation over 30 days. Similarly, Nasopore is an FDA-approved fragmentable nasal dressing that is used as a stent. Kenalog soaking the Nasopore is thought to act as the functional equivalent of the mometasone furoate found in the Propel stent, but this use is investigational. The effect of stenting and its consequences on the outcomes of FDO specifically has also not been well studied.Recent randomized-controlled trial of Propel stent placement after frontal sinusotomy (a less extensive form of frontal sinus surgery compared to FDO procedure) showed improvement in outcomes compared to no stent placement and no major complications.There are no known randomized-controlled trials to date of propel stent placement or Nasopore-soaked Kenalog placement after FDO procedure. We wish, therefore, to perform a randomized trial to compare the efficacy and outcomes of Nasopore-soaked kenalog versus propel stenting.
Interventions
DEVICENasopore
Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract
DEVICEPropel
Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.
Sponsors
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients eligible for the study and consenting to participate will be randomly assigned to one of two treatment groups: 1) Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract and 2) Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.
Intervention model description
Single-blind (Subject) randomized, active control study. Subjects will be randomized 1:1 using the rand function in Microsoft Excel program.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients able to speak and understand English * Patients for whom frontal drill out procedure is medically indicated
Exclusion criteria
* Patients who are cognitively impaired and unable to consent * Patients who are not candidates for Frontal Drill out * Patients with contraindications to PROPEL Mini sinus implant or Kenalog soaked nasopore: known hypersensitivity to mometasone furoate, Kenalog, lactide, glycolide or caprolactone copolymers * Non-English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Sino-Nasla Outcome Test (SNOT-22) Scores | After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24. | To compare the difference in mean post-operative SNOT-22 scores between the Propel stent and Nasopore groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Postoperative Complications, Devices | After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24. | To compare the incidence of other surgical postoperative complications (diagnosed post-operative cerebrospinal fluid (CSF) leak, epistaxis requiring treatment, adhesions) between Propel stent and Nasopore. |
| Surgical Postoperative Complications, Frontal Sinus Pathology | After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24. | To ascertain the incidence of surgical complications based on the specific frontal sinus pathology. |
Countries
United States
Participant flow
Recruitment details
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Participants by arm
| Arm | Count |
|---|---|
| Nasopore Group Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.
Nasopore: Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. | 0 |
| Propel Stent Group Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.
Propel: Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Propel Stent Group | Total | Nasopore Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 0 participants | 0 participants | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
Change From Baseline of Sino-Nasla Outcome Test (SNOT-22) Scores
To compare the difference in mean post-operative SNOT-22 scores between the Propel stent and Nasopore groups.
Time frame: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.
Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Secondary
Surgical Postoperative Complications, Devices
To compare the incidence of other surgical postoperative complications (diagnosed post-operative cerebrospinal fluid (CSF) leak, epistaxis requiring treatment, adhesions) between Propel stent and Nasopore.
Time frame: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.
Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Secondary
Surgical Postoperative Complications, Frontal Sinus Pathology
To ascertain the incidence of surgical complications based on the specific frontal sinus pathology.
Time frame: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.
Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.