- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
- 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?
- Is there a difference noted among ED providers with different levels of training?
- Is there an association between initial satisfaction scores and wound outcome?
- 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Twin Cities, Minnesota, United States
- Children's Hospitals and Clinics of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cosmetic outcome
Time Frame: 6 months
|
Cosmetic Visual Analog Score and the Wound Evaluation Score
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction score
Time Frame: 6 months
|
Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"
|
6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1108-081
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Facial Lacerations
-
Children's Hospitals and Clinics of MinnesotaWithdrawnFacial and Scalp LacerationsUnited States
-
University of California, IrvineNot yet recruitingFacial LacerationUnited States
-
University of Texas at AustinCompletedFacial LacerationUnited States
-
University of Texas at AustinNot yet recruitingAnxiety | Facial Laceration
-
University of California, San FranciscoCentral California Faculty Medical GroupRecruiting
-
Universitätsklinikum Hamburg-EppendorfCompleted
-
University of Texas Southwestern Medical CenterCompletedPerineal LacerationsUnited States
-
Lund University HospitalCompletedPerineal LacerationsSweden
-
University of AarhusAarhus University Hospital; Danish Research Agency; Aase and Ejnar Danielsens... and other collaboratorsCompletedEpisiotomy | Perineal LacerationsDenmark
-
University of PennsylvaniaTerminatedThrough-and-through Lip LacerationsUnited States