Evaluation of Skin Affix in the Emergency Room

• Sponsor: Medline Industries (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02223689
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Months): 26.1
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.

Condition or Disease	Intervention/Treatment	Phase
Wounds	Procedure: Skin Affix	Phase 4

Detailed Description

Subjects were approached for recruitment in the ED when discussing closure options by the physician. Only subjects deemed appropriate for skin glue closures by their treating physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and at 14 days following the ED visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Skin Affix Surgical adhesive	Procedure: Skin Affix

Outcome Measures

Primary Outcome Measures

1. Wound Closure at Discharge [14 days]

   Wounds remained closed following application of Skin Affix

Secondary Outcome Measures

1. Change in Pain Following Application [15 minutes Post Application]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Greater than 5 years of age

• Requires the use of a surgical skin adhesive

• Informed consent signed

Exclusion Criteria:

• Sensitivity to topical adhesive products or formaldehyde

• Hx keloid formation, hypotension, diabetes, blood clotting disorders

• Wound infections

• mucosal surfaces or skin exposed to body fluids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MetroHealth System	Cleveland	Ohio	United States	44109

Sponsors and Collaborators

• Medline Industries

Investigators

• Principal Investigator: Jon Schrock, MD, Metro Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medline Industries
• ClinicalTrials.gov Identifier: NCT02223689
• Other Study ID Numbers: R14-008
• First Posted: Aug 22, 2014
• Last Update Posted: Aug 7, 2019
• Last Verified: Feb 1, 2016

• Keywords provided by Medline Industries: SkinAffix
• Additional relevant MeSH terms: Emergencies

Study Results

Participant Flow

Arm/Group Title	Skin Affix
Arm/Group Description	Surgical adhesive (Skin Affix) applied during wound closure in ED
Period Title: Overall Study
STARTED	35
COMPLETED	35
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Skin Affix
Arm/Group Description	Surgical adhesive Skin Affix
Overall Participants	35
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	33.1
Sex: Female, Male (Count of Participants)
Female	16 45.7%
Male	19 54.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 25.7%
White	24 68.6%
More than one race	2 5.7%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Wound Closure at Discharge
Description	Wounds remained closed following application of Skin Affix
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Skin Affix
Arm/Group Description	Surgical adhesive
Measure Participants	35
Number [percent of participants]	100 285.7%

2. Secondary Outcome

Title	Change in Pain Following Application
Description	Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.
Time Frame	15 minutes Post Application

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Change in Pain Following Application
Arm/Group Description	Pain assessed through a pain score 0-5. 0 = no pain, 5 = highest pain.
Measure Participants	35
Increase in Pain	8.6 24.6%
Decrease in Pain	22.9 65.4%
No change in Pain	57.1 163.1%

Adverse Events

Time Frame	1 year
Arm/Group Title	Skin Affix
Arm/Group Description	Surgical adhesive Skin Affix
All Cause Mortality
	Skin Affix
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Serious Adverse Events
	Skin Affix
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Other (Not Including Serious) Adverse Events
	Skin Affix
	Affected / at Risk (%)	# Events
Total	9/35 (25.7%)
Surgical and medical procedures
Procedural bleeding	3/35 (8.6%)	3
Dihiscence	4/35 (11.4%)	4
Infection	2/35 (5.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.