Trial Outcomes & Findings for Octylseal Surgical Adhesive in General Surgery (NCT NCT01514383)

Results Overview

Primary incision wound length treatment in adult and pediatric general surgery

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

During Surgery

Results posted on

2019-05-07

Participant milestones
Measure	Surgical Adhesive Cyanoacrylate (Octylseal ): surgical adhesive
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Octylseal Surgical Adhesive in General Surgery

Baseline characteristics by cohort
Measure	Octylseal n=34 Participants
Age, Continuous Adult	47.5 years STANDARD_DEVIATION 17.5 • n=5 Participants
Age, Continuous Pediatric	11.3 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	34 Participants n=5 Participants

Timeframe: During Surgery

Primary incision wound length treatment in adult and pediatric general surgery

Outcome measures
Measure	Wound Length Closure of Paticipants Treated With Octylseal n=34 Participants
Wound Length Closure Adult	28.97 milimeters Standard Deviation 24.68
Wound Length Closure Pediatric	21.00 milimeters Standard Deviation 10.98

Timeframe: At Surgery

Population: All 34 participants

Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst

Outcome measures
Measure	Wound Length Closure of Paticipants Treated With Octylseal n=34 Participants
Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale	34 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Octylseal n=34 participants at risk
Infections and infestations Infection	2.9% 1/34 • Number of events 1 • 14 days

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