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

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ClinicalTrials.gov Identifier: NCT01514084
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Facial Lacerations

Study Design

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Tears
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

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


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


Eligibility Criteria

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 Posted: January 20, 2012    Key Record Dates
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