Trial Outcomes & Findings for Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis (NCT NCT00863356)
NCT ID: NCT00863356
Last Updated: 2012-11-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Removal: 48 hours. Follow-up: 1 week.
Results posted on
2012-11-28
Participant Flow
Patients were recruited from a tertiary rhinology fellowship training clinic from January 2009 to November 2009.
Participant milestones
| Measure |
Epistaxis Group
Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.
One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
Baseline characteristics by cohort
| Measure |
Epistaxis Group
n=20 Participants
Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.
One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age Continuous
|
67 years
STANDARD_DEVIATION 19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Removal: 48 hours. Follow-up: 1 week.Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From procedure to hemostasis.Population: All enrolled subjects
Successful hemostasis prior to leaving physician's office
Outcome measures
| Measure |
Epistaxis Group
n=20 Participants
Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.
One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material.
|
|---|---|
|
Hemostasis Success
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: Removal: 48 hours. Follow-up: 1 week.Outcome measures
Outcome data not reported
Adverse Events
Epistaxis Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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