Trial Outcomes & Findings for Nasal Septal Flap for Donor Site Reconstruction (NCT NCT03159624)
NCT ID: NCT03159624
Last Updated: 2023-06-28
Results Overview
Mean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative remucosalization is a Likert scale ranging from 0% (no remucosalization) to 100% (complete remucosalization), with higher scores representing better healing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
2 weeks, 6 weeks, 12 weeks
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
Treatment Group
2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft
Doyle silastic sheet: Doyle silastic sheet
|
Control Group
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone
Doyle silastic sheet: Doyle silastic sheet
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
26
|
|
Overall Study
COMPLETED
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nasal Septal Flap for Donor Site Reconstruction
Baseline characteristics by cohort
| Measure |
Treatment Group
n=21 Participants
2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft
Doyle silastic sheet: Doyle silastic sheet
|
Control Group
n=26 Participants
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone
Doyle silastic sheet: Doyle silastic sheet
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, 6 weeks, 12 weeksMean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative remucosalization is a Likert scale ranging from 0% (no remucosalization) to 100% (complete remucosalization), with higher scores representing better healing.
Outcome measures
| Measure |
Treatment Group
n=21 Participants
2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft
Doyle silastic sheet: Doyle silastic sheet
|
Control Group
n=26 Participants
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone
Doyle silastic sheet: Doyle silastic sheet
|
|---|---|---|
|
Mean Change in Post-operative Remucosalization at the Donor Site
2 weeks
|
47.8 percentage of remucosalization
Interval 40.3 to 55.3
|
37.8 percentage of remucosalization
Interval 31.1 to 44.5
|
|
Mean Change in Post-operative Remucosalization at the Donor Site
6 weeks
|
49.7 percentage of remucosalization
Interval 41.6 to 57.8
|
43.5 percentage of remucosalization
Interval 36.7 to 50.3
|
|
Mean Change in Post-operative Remucosalization at the Donor Site
12 weeks
|
73.9 percentage of remucosalization
Interval 63.8 to 83.9
|
65.3 percentage of remucosalization
Interval 56.97 to 73.7
|
|
Mean Change in Post-operative Remucosalization at the Donor Site
overall change
|
57.1 percentage of remucosalization
Interval 52.1 to 62.2
|
48.9 percentage of remucosalization
Interval 45.1 to 52.7
|
PRIMARY outcome
Timeframe: 2 weeks, 6 weeks, 12 weeksMean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative crusting is a Likert scale ranging from 0 (no crusting) to 10 (complete crusting), with lower scores representing better healing.
Outcome measures
| Measure |
Treatment Group
n=21 Participants
2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft
Doyle silastic sheet: Doyle silastic sheet
|
Control Group
n=26 Participants
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone
Doyle silastic sheet: Doyle silastic sheet
|
|---|---|---|
|
Mean Change in Post-operative Locoregional Crusting at Donor Site
12 weeks
|
2.64 score on a scale
Interval 1.48 to 3.8
|
2.92 score on a scale
Interval 2.17 to 3.66
|
|
Mean Change in Post-operative Locoregional Crusting at Donor Site
2 weeks
|
3.50 score on a scale
Interval 2.99 to 4.01
|
4.22 score on a scale
Interval 3.5 to 4.94
|
|
Mean Change in Post-operative Locoregional Crusting at Donor Site
6 weeks
|
4.22 score on a scale
Interval 3.03 to 5.41
|
5.2 score on a scale
Interval 4.17 to 6.24
|
|
Mean Change in Post-operative Locoregional Crusting at Donor Site
overall change
|
3.45 score on a scale
Interval 2.97 to 3.93
|
4.11 score on a scale
Interval 3.63 to 4.59
|
PRIMARY outcome
Timeframe: 2 weeks, 6 weeks, 12 weeksMean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative edema is a Likert scale ranging from 0 (no edema) to 10 (severe edema), with lower scores representing better healing.
Outcome measures
| Measure |
Treatment Group
n=21 Participants
2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft
Doyle silastic sheet: Doyle silastic sheet
|
Control Group
n=26 Participants
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone
Doyle silastic sheet: Doyle silastic sheet
|
|---|---|---|
|
Mean Change in Post-operative Edema at the Donor Site
overall change
|
2.95 score on a scale
Interval 2.73 to 3.18
|
3.11 score on a scale
Interval 2.86 to 3.35
|
|
Mean Change in Post-operative Edema at the Donor Site
2 weeks
|
3.34 score on a scale
Interval 2.94 to 3.75
|
3.52 score on a scale
Interval 3.16 to 3.89
|
|
Mean Change in Post-operative Edema at the Donor Site
6 weeks
|
3.25 score on a scale
Interval 2.74 to 3.76
|
3.15 score on a scale
Interval 2.75 to 3.55
|
|
Mean Change in Post-operative Edema at the Donor Site
12 weeks
|
2.26 score on a scale
Interval 1.84 to 2.7
|
2.65 score on a scale
Interval 2.11 to 3.19
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=21 participants at risk
2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft
Doyle silastic sheet: Doyle silastic sheet
|
Control Group
n=26 participants at risk
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone
Doyle silastic sheet: Doyle silastic sheet
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
minor septal perforation
|
19.0%
4/21 • Number of events 4 • 12 weeks
|
23.1%
6/26 • Number of events 6 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
development of transverse synechiae between septum and inferior turbinate
|
14.3%
3/21 • Number of events 3 • 12 weeks
|
7.7%
2/26 • Number of events 2 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place