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

This study is currently recruiting participants.
Verified August 2012 by Children's Hospitals and Clinics of Minnesota
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01514084
First received: January 12, 2012
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  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:

MedlinePlus related topics: Cosmetics
U.S. FDA Resources

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

Primary Outcome Measures:
  • Cosmetic outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cosmetic Visual Analog Score and the Wound Evaluation Score


Secondary Outcome Measures:
  • Satisfaction score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"


Estimated Enrollment: 160
Study Start Date: February 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514084

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Recruiting
Twin Cities, Minnesota, United States
Contact: Heidi Vander Velden, MS     612-813-7892        
Principal Investigator: Kristin Dettmer, NP            
Principal Investigator: Erin Fritz, NP            
Sub-Investigator: Henry Ortega, MD            
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
Study First Received: January 12, 2012
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Facies
Lacerations
Disease Attributes
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013