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NCT02223689 Clinical Trial

Evaluation of Skin Affix in the Emergency Room

Wounds Clinical Trial

Official title:
Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02223689
Other study ID # R14-008
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2014
Est. completion date September 2016

Study information
Verified date February 2016
Source Medline Industries
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date September 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Skin Affix

Locations
Country Name City State
United States MetroHealth System Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound Closure at Discharge Wounds remained closed following application of Skin Affix 14 days
Secondary Change in Pain Following Application Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain. 15 minutes Post Application
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