Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis
Study Details
Study Description
Brief Summary
The purpose of this study is to learn whether there is a difference in postoperative (after surgery) endoscopic appearance of the sinus cavities (the way that the sinuses look through a camera) between sinuses that receive one of two types of resorbable steroid eluting sinus packing (a sponge-like material which dissolves within several days while releasing a steroid): 1) Propel Implant or 2) Nasopore soaked with triamcinolone at the time of endoscopic sinus surgery (ESS) for chronic rhinosinusitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
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The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.
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Nasopore soaked with triamcinolone. This "packing' is a sponge-like material which dissolves while releasing triamcinolone, which is another type of steroid. Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.
Both of these procedures are currently used regularly by Dr. Pearlman in practice at the conclusion of ESS for treatment of chronic rhinosinusitis. As standard of care, treatment is determined intraoperatively (during surgery), at the discretion of the surgeon. In this study, each subject will have both treatments (one in each cavity). The 'experimental' aspect relates to directly comparing the two procedures.
This research study is being done because there is currently a lack of consensus regarding the optimal nasal packing regimen. There have been no comparison studies and practice patterns vary widely. Our study looks to compare the Propel implant to Nasopore packing soaked in Triamcinolone.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Propel Implant The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA. |
Device: Propel 'implant'
The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.
|
| Other: Nasopore soaked with triamcinolone This "packing' is a sponge-like material which dissolves while releasing triamcinolone, which is another type of steroid. Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA. |
Drug: Triamcinolone
Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.
Device: Nasopore
This "packing' is a sponge-like material which dissolves while releasing triamcinolone.
|
Outcome Measures
Primary Outcome Measures
- Change from Pre-operative score in Patient's nasal endoscopy, as measured by Perioperative Sinus Endoscopy (POSE) Scores [Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.]
Validated endoscopy grading score.The score is calculated by determining several characteristics of the appearance of the sinus cavities. The score ranges from 0-32 (or 0-40 if frontal and sphenoid sinuses are opened at the time of surgery). A higher score indicates more severe disease.
Secondary Outcome Measures
- Change from Pre-operative score in Patient's nasal endoscopy, as measured by the Lund-Kennedy Endoscopic Score. [Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.]
The score is calculated by determining the amount of polyp, edema, and secretion in the nasal cavity on both sides. The score ranges from 0-12, with higher scores indicating more severe disease.
- Change from Pre-operative score in Patient's sinonasal quality of life, as measured by SNOT-22 (Sino-nasal outcome test) [Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.]
Validated disease-specific quality of life questionnaire (22 questions). The score ranges from 0-110, with higher scores indicating more severe disease.
Other Outcome Measures
- Findings on the pre-operative CT scan, as measured by Lund-MacKay CT Scores [Pre-operatively]
The score is calculated by determining the amount of polyp, edema, and secretion in the nasal cavity on both sides. The score ranges from 0-12, with higher scores indicating more severe disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
-Adult patients undergoing endoscopic sinus surgery for the treatment of chronic rhinosinusitis refractory to medical management
Exclusion Criteria:
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Patients ineligible for informed consent
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Patients unwilling or unable to comply with the postoperative visits necessary for data collection
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Patients with a history of intolerance to triamcinolone
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Patients with suspected systemic inflammatory disease, cystic fibrosis, and any contraindication to systemic corticosteroids.
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As standard of care, the PI does not operate on pregnant patients. A pregnant patient would not be a candidate for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medicine | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: Aaron Pearlman, MD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1802018943