Facial Lacerations Clinical Trial
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | November 2013 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 17 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Hospitals and Clinics of Minnesota | Twin Cities | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospitals and Clinics of Minnesota |
United States,
Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cosmetic outcome | Cosmetic Visual Analog Score and the Wound Evaluation Score | 6 months | No |
| Secondary | Satisfaction score | Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied" | 6 months | No |