Evaluation of Skin Affix in the Emergency Room

NCT ID: NCT02223689

Last Updated: 2019-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Skin Affix

Surgical adhesive

Group Type EXPERIMENTAL

Skin Affix

Intervention Type PROCEDURE

Interventions

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Skin Affix

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medline Industries

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon Schrock, MD

Role: PRINCIPAL_INVESTIGATOR

Metro Hospital

Locations

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MetroHealth System

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R14-008

Identifier Type: -

Identifier Source: org_study_id

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