Evaluation of Skin Affix in the Emergency Room

Medline Industries

Status and phase: Completed; Phase 4

Conditions: Wounds

Treatments: Procedure: Skin Affix

Study type: Interventional

Funder types: Industry

Identifiers

NCT02223689

R14-008

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Skin Affix

Experimental group

Description:

Surgical adhesive

Treatment:

Procedure: Skin Affix