Trial Outcomes & Findings for Evaluation of Skin Affix in the Emergency Room (NCT NCT02223689)

NCT ID: NCT02223689

Last Updated: 2019-08-07

Results Overview

Wounds remained closed following application of Skin Affix

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2019-08-07

Participant Flow

Participant milestones

Measure	Skin Affix Surgical adhesive (Skin Affix) applied during wound closure in ED
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Skin Affix in the Emergency Room

Baseline characteristics by cohort

Measure	Skin Affix n=35 Participants Surgical adhesive Skin Affix
Age, Continuous	33.1 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Wounds remained closed following application of Skin Affix

Outcome measures

Measure	Skin Affix n=35 Participants Surgical adhesive
Wound Closure at Discharge	100 percent of participants

SECONDARY outcome

Timeframe: 15 minutes Post Application

Population: Participants were asked 15 min after application to rate any change in pain as decreased, increased or no change.

Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.

Outcome measures

Measure	Skin Affix n=35 Participants Surgical adhesive
Change in Pain Following Application Increase in Pain	8.6 percent of participants
Change in Pain Following Application Decrease in Pain	22.9 percent of participants
Change in Pain Following Application No change in Pain	57.1 percent of participants

Adverse Events

Skin Affix

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Skin Affix n=35 participants at risk Surgical adhesive Skin Affix
Surgical and medical procedures Procedural bleeding	8.6% 3/35 • Number of events 3 • 1 year
Surgical and medical procedures Dihiscence	11.4% 4/35 • Number of events 4 • 1 year
Surgical and medical procedures Infection	5.7% 2/35 • Number of events 2 • 1 year

Additional Information

Lori Rotolo

Medline Industries, Inc.

Phone: 8476434640

Email: lrotolo@medline.com

Results disclosure agreements

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