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

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

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 days

wound closure measured baseline to 14 days

Outcome measures

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 days

Adverse events reported

Outcome measures

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

Ed Drower

Medline Industries, Inc.

Phone: 847-643-3874

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place