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Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514084
First Posted: January 20, 2012
Last Update Posted: April 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
  Purpose

Facial lacerations are commonly treated in the emergency department. The nature of the injury leads to a great deal of concern about the long-term cosmetic appearance of the wounds.

Research Questions

  1. What is the association between wound characteristics, wound management in the ED, patient satisfaction in the ED, and patient-rated cosmetic appearance of sutured wounds?
  2. Is there a difference noted among ED providers with different levels of training?
  3. Is there an association between initial satisfaction scores and wound outcome?
  4. Is there an association between short term and long term wound scores?

Design This is a non-randomized, prospective, observational study of patients who present to the ED seeking treatment for facial laceration repair.


Condition
Facial Lacerations

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Cosmetic outcome [ Time Frame: 6 months ]
    Cosmetic Visual Analog Score and the Wound Evaluation Score


Secondary Outcome Measures:
  • Satisfaction score [ Time Frame: 6 months ]
    Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"


Estimated Enrollment: 160
Study Start Date: February 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
PEM group
Patients whose lacerations have been repaired by PEM trained physicians.
GP group
Patients whose lacerations have been repaired by general pediatricians.
PNP group
Patients whose lacerations have been repaired by PNPs.
RN group
Patients whose lacerations have been repaired by suture RNs.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric emergency department
Criteria

Inclusion Criteria:

  • Families presenting to the ED for repair of facial laceration will be approached for study inclusion if:

    • Their child seeking treatment is less than 18 years of age
    • The laceration was sustained less than 12 hours prior to presentation to Children's ED
    • They speak English

Exclusion Criteria:

  • Families presenting to the ED for repair of facial laceration will be excluded from study participation if they:

    • Are medically complex children
    • Have a history of pre-existing coagulopathy or collagen vascular disease
    • Have a history of immunodeficiency or diabetes mellitus
    • Are suspected of non-accidental trauma
    • Have wounds that could be approximated by tissue adhesives
    • Have animal or human bites
    • Have gross contamination
    • Have puncture wounds
    • Have lacerations of tendon/nerve/cartilage
    • Have scalp lacerations
    • Do not speak English
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514084


Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Twin Cities, Minnesota, United States
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
  More Information

Publications:
Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01514084     History of Changes
Other Study ID Numbers: 1108-081
First Submitted: January 12, 2012
First Posted: January 20, 2012
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by Children's Hospitals and Clinics of Minnesota:
laceration
emergency
cosmetic outcomes
patient satisfaction
suture

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries