Trial Outcomes & Findings for Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings (NCT NCT04970966)
NCT ID: NCT04970966
Last Updated: 2026-02-11
Results Overview
Patient-reported pain visual analogue scale during postoperative debridement of ethmoid cavity. The minimum score is 1, which reflects no pain, and the maximum score is 10, which reflects an extreme amount of pain.
COMPLETED
NA
30 participants
1 week after surgery
2026-02-11
Participant Flow
This was a split-person (within-participant) design: each participant contributed one ethmoid cavity to the Hydrogel arm and the contralateral cavity to the Chitosan arm. Therefore, the same participants are counted in both arms within a Milestone row, which is expected.
Unit of analysis: Right or Left Ethmoid Cavity
Participant milestones
| Measure |
Hydrogel (Treatment Side)
Participant had hydrogel placed in ethmoid cavity.
|
Chitosan-based Polymer (Control)
Participant had chitosan-based polymer placed in ethmoid cavity
|
|---|---|---|
|
Week 1 Follow-up
STARTED
|
30 30
|
30 30
|
|
Week 1 Follow-up
COMPLETED
|
30 30
|
30 30
|
|
Week 1 Follow-up
NOT COMPLETED
|
0 0
|
0 0
|
|
Week 4 Follow-up
STARTED
|
30 30
|
30 30
|
|
Week 4 Follow-up
COMPLETED
|
30 30
|
30 30
|
|
Week 4 Follow-up
NOT COMPLETED
|
0 0
|
0 0
|
|
Weed 12 Follow-up
STARTED
|
30 30
|
30 30
|
|
Weed 12 Follow-up
COMPLETED
|
28 28
|
28 28
|
|
Weed 12 Follow-up
NOT COMPLETED
|
2 2
|
2 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings
Baseline characteristics by cohort
| Measure |
Participants
n=30 Participants
All randomized participants who underwent bilateral total ethmoidectomy
|
|---|---|
|
Age, Continuous
|
48.5 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
History of Endoscopic Sinus Surgery
|
6 Participants
n=41 Participants
|
|
Nasal Polyps
|
11 Participants
n=41 Participants
|
|
Allergic Rhinitis
|
10 Participants
n=41 Participants
|
|
Asthma
|
6 Participants
n=41 Participants
|
|
Diabetes
|
4 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 1 week after surgeryPatient-reported pain visual analogue scale during postoperative debridement of ethmoid cavity. The minimum score is 1, which reflects no pain, and the maximum score is 10, which reflects an extreme amount of pain.
Outcome measures
| Measure |
Hydrogel (Treatment Side)
n=30 Participants
Participant had hydrogel placed in ethmoid cavity.
|
Chitosan-based Polymer (Control)
n=30 Participants
Participant had chitosan-based polymer placed in ethmoid cavity
|
|---|---|---|
|
Pain During Debridement
|
4 Pain Score
Interval 2.5 to 5.5
|
5 Pain Score
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: 1 week after surgeryTime required to perform sinonasal cavity debridement for ethmoid cavity 1 week after surgery
Outcome measures
| Measure |
Hydrogel (Treatment Side)
n=30 Participants
Participant had hydrogel placed in ethmoid cavity.
|
Chitosan-based Polymer (Control)
n=30 Participants
Participant had chitosan-based polymer placed in ethmoid cavity
|
|---|---|---|
|
Debridement Time
|
1.96 minutes
Interval 1.05 to 2.89
|
1.57 minutes
Interval 1.08 to 2.06
|
SECONDARY outcome
Timeframe: 4 weeks after surgeryPopulation: Data were available for 28 participants per arm at this time point.
Mucosal edema was assessed via endoscopic examination at 4 weeks postoperatively. Edema was recorded as present or absent based on investigator visual assessment using standard postoperative sinus endoscopy criteria
Outcome measures
| Measure |
Hydrogel (Treatment Side)
n=28 Participants
Participant had hydrogel placed in ethmoid cavity.
|
Chitosan-based Polymer (Control)
n=28 Participants
Participant had chitosan-based polymer placed in ethmoid cavity
|
|---|---|---|
|
Number of Participants With Mucosal Edema
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after surgeryAdhesions were assessed during endoscopic examination at 12 weeks postoperatively. Presence of adhesions was determined by direct visualization of scar bands between the middle turbinate and lateral nasal wall.
Outcome measures
| Measure |
Hydrogel (Treatment Side)
n=28 Participants
Participant had hydrogel placed in ethmoid cavity.
|
Chitosan-based Polymer (Control)
n=28 Participants
Participant had chitosan-based polymer placed in ethmoid cavity
|
|---|---|---|
|
Number of Participants With Postoperative Adhesions at 12 Weeks
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 week after surgeryPopulation: Two participants did not have evaluable endoscopic data at this time point and were excluded from this analysis.
Bleeding was evaluated during the week 1 postoperative debridement visit. Presence of bleeding was recorded if any mucosal bleeding was visualized on nasal endoscopy in the ethmoid cavity.
Outcome measures
| Measure |
Hydrogel (Treatment Side)
n=28 Participants
Participant had hydrogel placed in ethmoid cavity.
|
Chitosan-based Polymer (Control)
n=28 Participants
Participant had chitosan-based polymer placed in ethmoid cavity
|
|---|---|---|
|
Number of Participants With Postoperative Bleeding at Week 1 Debridement
|
23 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 1 week after surgeryPopulation: Two participants did not have evaluable endoscopic data at this time point and were excluded from this analysis.
Residual bioresorbable dressing material in the ethmoid cavity was assessed endoscopically at 1 week. Greater than 50% residual material was recorded when more than half of the originally placed dressing remained visible.
Outcome measures
| Measure |
Hydrogel (Treatment Side)
n=28 Participants
Participant had hydrogel placed in ethmoid cavity.
|
Chitosan-based Polymer (Control)
n=28 Participants
Participant had chitosan-based polymer placed in ethmoid cavity
|
|---|---|---|
|
Number of Participants With Greater Than 50% Residual Dressing in Ethmoid Cavity at Week 1
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after surgeryThe need for further intervention postoperatively 4 weeks after surgery as evaluated by an independent blinded reviewer of the video-endoscopy
Outcome measures
| Measure |
Hydrogel (Treatment Side)
n=30 Participants
Participant had hydrogel placed in ethmoid cavity.
|
Chitosan-based Polymer (Control)
n=30 Participants
Participant had chitosan-based polymer placed in ethmoid cavity
|
|---|---|---|
|
Number of Participants Requiring Additional Postoperative Intervention by Week 4
|
1 Participants
|
4 Participants
|
Adverse Events
Hydrogel (Treatment Side)
Chitosan-based Polymer (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place