NCT02223689

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

July 11, 2019

Completed
Last Updated

August 7, 2019

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

March 27, 2014

Results QC Date

August 28, 2017

Last Update Submit

July 29, 2019

Conditions

Wounds

Keywords

SkinAffix

Outcome Measures

Primary Outcomes (1)

  • Wound Closure at Discharge

    Wounds remained closed following application of Skin Affix

    14 days

Secondary Outcomes (1)

  • Change in Pain Following Application

    15 minutes Post Application

Study Arms (1)

Skin Affix

EXPERIMENTAL

Surgical adhesive

Procedure: Skin Affix

Interventions

Skin AffixPROCEDURE
Skin Affix

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than 5 years of age
  • Requires the use of a surgical skin adhesive
  • Informed consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth System

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
Lori Rotolo
Organization
Medline Industries, Inc.
lrotolo@medline.com
8476434640

Study Officials

  • Jon Schrock, MD

    Metro Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

August 22, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

August 7, 2019

Results First Posted

July 11, 2019

Record last verified: 2016-02

Locations

US(1)