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OpenTrials
Completed

NCT Number: NCT01514084

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

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospitals and Clinics of Minnesota

Twin Cities, Minnesota, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cosmetic outcome

    Time frame: 6 months

    Cosmetic Visual Analog Score and the Wound Evaluation Score

Secondary outcomes

  1. Satisfaction score

    Time frame: 6 months

    Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 20, 2012
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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