Trial Outcomes & Findings for Skin Incision Adhesive in Pediatrics (NCT NCT01514396)
NCT ID: NCT01514396
Last Updated: 2018-12-04
Results Overview
wound closure measured baseline to 14 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
baseline to 14 days
Results posted on
2018-12-04
Participant Flow
Participant milestones
| Measure |
Surgical Glue
Surgiseal
Surgiseal: surgical glue To determine if SurgiSealâ„¢ can effectively seal epidermal wounds in children while not causing any adverse events.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Skin Incision Adhesive in Pediatrics
Baseline characteristics by cohort
| Measure |
Surgical Glue
n=8 Participants
Surgiseal
Surgiseal: surgical glue
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 14 dayswound closure measured baseline to 14 days
Outcome measures
| Measure |
Wound Closure
n=8 Participants
Number of Participants with Wound Closure baseline to 14 days from discharge
|
|---|---|
|
Number of Participants With Wound Closure
|
8 participants
|
SECONDARY outcome
Timeframe: 14 daysAdverse events reported
Outcome measures
| Measure |
Wound Closure
n=8 Participants
Number of Participants with Wound Closure baseline to 14 days from discharge
|
|---|---|
|
Adverse Events Related to Wound Closure
|
0 participants
|
Adverse Events
Surgical Glue
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