Effect of a dexamethasone Sinu‐Foam <sup>TM</sup> middle meatal spacer on endoscopic sinus surgery outcomes: A randomized, double‐blind, placebo‐controlled trial
Bibliographic record
Abstract
BACKGROUND: Off-label drug eluting middle-meatal spacers have shown promising results for improving clinical outcomes following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). This study evaluates a dexamethasone Sinu-Foam™ spacer following ESS for CRS without nasal polyposis (CRSsNP). METHODS: Patients with CRSsNP (n = 36) were enrolled into a double-blind, placebo-controlled trial and randomized into either a treatment arm (dexamethasone Sinu-Foam™ mixture; n = 18) or placebo arm (Sinu-Foam™ alone; n = 18). Therapeutic outcomes were evaluated at 1 week, 4 weeks, and 3 months using sinonasal endoscopy and graded using the Lund-Kennedy scoring system. Postoperative care included nasal saline irrigations and a short course of systemic steroids. RESULTS: All patients completed the study follow-up period. Both study arms experienced significant improvement in endoscopic grading over the study duration (p < 0.001). There was no difference in average endoscopic scores between the treatment and placebo groups at 1 week, 4 weeks, and 3 months (all p > 0.489). CONCLUSION: This study demonstrated that an off-label drug-eluting middle-meatal spacer of dexamethasone and Sinu-Foam™ does not improve endoscopic outcomes in the early postoperative period following ESS when combined with postoperative saline irrigations and a short course of systemic steroids.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".