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OpenTrials
Completed

NCT Number: NCT02223689

Evaluation of Skin Affix in the Emergency Room

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

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Key information

Conditions

Wounds Wounds and Injuries

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MetroHealth System

Cleveland, Ohio, 44109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Affix

Procedure

Primary outcomes

  1. Wound Closure at Discharge

    Time frame: 14 days

    Wounds remained closed following application of Skin Affix

Secondary outcomes

  1. Change in Pain Following Application

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2014
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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