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

Completed

• Conditions: Facial Lacerations

• Registration Number: NCT01514084
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-20
• Study Start: 2012-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-21
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cosmetic outcome	6 months	Cosmetic Visual Analog Score and the Wound Evaluation Score

Secondary Outcome Measures

Name	Time	Method
Satisfaction score	6 months	Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"

Trial Locations

Locations (1)

Children's Hospitals and Clinics of Minnesota; 🇺🇸 Twin Cities, Minnesota, United States