Chronic Rhinosinusitis (Diagnosis)
Conditions
Brief summary
The purpose of this study is to compare how two different post-surgical treatments that both deliver steroids to the frontal sinus opening affect your healing after frontal sinus surgery.
Detailed description
This is a single center, randomized & controlled trial comparing the efficacy of the Propel mini stent or Propel contour stent vs. Nasopore impregnated with Triamcinolone Acetonide at reducing frontal sinus opening stenosis and polypoid edema after endoscopic sinus surgery in patients with chronic rhinosinusitis with polyposis. Eligible subjects who undergo standard of care bilateral frontal sinusotomy will have each frontal sinus randomly assigned to either a Propel mini or contour steroid eluding stent or a Nasopore nasal dressing impregnated with 2.5 ml of Triamcinolone Acetonide 40 mg/ml. Specific Propel stent will be chosen based on the shape of frontal sinus opening and best fit as decided by the operating Surgeon. Patients will be reassessed on approximately post-operative day 7, 14, 30, 90 days, 6 months, and 12 months at their standard of care follow-up visits. On the day 14 visit, the frontal sinus Propel stent and Nasopore will be completely removed per Standard of care. Video will be taken of the frontal sinus opening, and assessed for scarring/adhesions, presence of polypoid edema, frontal sinus patency, need for oral steroids or other interventions. Additionally, endoscopic scoring of frontal sinus by the above measures will be evaluated by 2 independent sinus surgeon reviewers. The reviewers will also be asked to rank the two frontal sinus openings as better, same or worse, compared to the opposite side
Interventions
DEVICEBioabsorbable steroid releasing sinus implant
After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
DEVICEBioabsorbable nasal dressing impregnated with steroid
After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 and older * Diagnosis of chronic rhinosinusitis with nasal polyps based on the American Academy of Otolaryngology-Head and Neck Surgery guidelines * Patient scheduled for bilateral endoscopic sinus surgery with evidence of bilateral frontal sinus disease based on Computed Tomography (Lund-Mackay score greater than or equal to 1) * At the time of surgery bilateral frontal sinusotomy of type Draf 2a or 2b was performed using the same technique on both sides * Bilateral endoscopic sinus surgery performed successfully without complication * Frontal sinus opening diameter greater than 4.0 mm achieved (4 mm olive tipped suction easily passed into frontal sinus)
Exclusion criteria
* Any patient who had frontal sinus surgery for tumor * Allergy to mometesone and/or triamcinolone * Frontal sinusotomy type Draf 1 or Draf 3 performed * One or both frontal sinus openings not amenable to implant placement * Patients with chronic oral steroid dependent conditions * Invasive fungal sinusitis * Immune deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing | 12 months | Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adhesion/Scarring Scale - Right Side | 12 months | Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement |
| Polypoid Edema Scale - Left Side | 12 months | Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement |
| Adhesion/Scarring Scale - Left Side | 12 months | Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement - Left side |
| Frontal Sinus Opening Size | 12 months | Frontal sinus opening greater than or equal to 4 mm for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid |
| Visualization of Frontal Sinus Roof | 12 months | Odds ratio of frontal sinus roof visualized for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid |
| Polypoid Edema Scale - Right Side | 12 months | Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Clinic was closed due to COVID-19 for 12 month follow up visit | 1 |
| Overall Study | Subjects chose not to attend the SOC 12 month follow up visit | 6 |
Baseline characteristics
| Characteristic | Bioabsorbable Steroid Releasing Sinus Implant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal
Time frame: 12 months
Population: Two subjects completed the 12 month follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing | propel sinus stent frontal sinusotomy side is better | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing | propel sinus stent frontal sinusotomy side is same | 1 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing | propel sinus stent frontal sinusotomy side is worse | 1 Participants |
Secondary
Adhesion/Scarring Scale - Left Side
Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement - Left side
Time frame: 12 months
Population: Data was collected from 3 subjects at 12 months for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Adhesion/Scarring Scale - Left Side | adhesion/scarring Likert scale score of 0 | 3 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Adhesion/Scarring Scale - Left Side | adhesion/scarring Likert scale score of 1 | 0 Participants |
Secondary
Adhesion/Scarring Scale - Right Side
Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement
Time frame: 12 months
Population: Data was collected from 3 subjects at 12 months for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Adhesion/Scarring Scale - Right Side | adhesion/scarring Likert scale score of 0 | 2 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Adhesion/Scarring Scale - Right Side | adhesion/scarring Likert scale score of 1 | 1 Participants |
Secondary
Frontal Sinus Opening Size
Frontal sinus opening greater than or equal to 4 mm for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid
Time frame: 12 months
Population: Data was collected from 3 subjects at 12 months for this outcome.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Frontal Sinus Opening Size | Left | Yes | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Frontal Sinus Opening Size | Left | No | 3 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Frontal Sinus Opening Size | Right | Yes | 1 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Frontal Sinus Opening Size | Right | No | 2 Participants |
Secondary
Polypoid Edema Scale - Left Side
Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement
Time frame: 12 months
Population: Data was collected from 3 subjects at 12 months for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Left Side | polypoid edema Likert score 2 | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Left Side | polypoid edema Likert score 0 | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Left Side | polypoid edema Likert score 1 | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Left Side | polypoid edema Likert score 3 | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Left Side | polypoid edema Likert score 4 | 3 Participants |
Secondary
Polypoid Edema Scale - Right Side
Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement
Time frame: 12 months
Population: Data was collected from 3 subjects at 12 months for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Right Side | polypoid edema Likert score 0 | 1 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Right Side | polypoid edema Likert score 1 | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Right Side | polypoid edema Likert score 2 | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Right Side | polypoid edema Likert score 3 | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Polypoid Edema Scale - Right Side | polypoid edema Likert score 4 | 2 Participants |
Secondary
Visualization of Frontal Sinus Roof
Odds ratio of frontal sinus roof visualized for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Visualization of Frontal Sinus Roof | Yes | 0 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Visualization of Frontal Sinus Roof | No | 2 Participants |
Post Hoc
Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal
Time frame: 30 Days
Population: Data was collected from 8 patients at day 30 for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing | propel sinus stent frontal sinusotomy side is better | 2 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing | propel sinus stent frontal sinusotomy side is same | 3 Participants |
| Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid | Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing | propel sinus stent frontal sinusotomy side is worse | 3 Participants |