Facial LacerationsNCT01514084
Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department
An observational study of Facial Lacerations, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Facial Lacerations
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric emergency department
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Have animal or human bites
- Have gross contamination
- Have puncture wounds
- Have lacerations of tendon/nerve/cartilage
- Have scalp lacerations
- Do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Twin Cities, Minnesota
About this study
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
Read more
- 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.
- Conditions
- Facial Lacerations
- Keywords
- laceration, emergency, cosmetic outcomes, patient satisfaction, suture
- Medical subject headings
- Lacerations, Emergencies, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic outcome
Cosmetic Visual Analog Score and the Wound Evaluation Score
Measured: 6 months
Secondary outcomes (1)
Satisfaction score
Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial LacerationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514084
- Sponsor's protocol ID
- 1108-081
- Status last verified
- Apr 2014
- First submitted
- 12 Jan 2012
- Last updated
- 23 Apr 2014
- Results posted
- No
Publications
Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6. doi: 10.1111/j.1553-2712.1998.tb02465.x.
PubMed 9660284
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department
- ClinicalTrials.gov ID
- NCT01514084
- Acronym / sponsor ID
- 1108-081
- Conditions
- Facial Lacerations
- Keywords
- laceration, emergency, cosmetic outcomes, patient satisfaction, suture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric emergency department
Key inclusion criteria (4 listed)
- Families presenting to the ED for repair of facial laceration will be approached for study inclusion if:
Key exclusion criteria (12 listed)
- Families presenting to the ED for repair of facial laceration will be excluded from study participation if they:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cosmetic outcome
Time frame: 6 months
Cosmetic Visual Analog Score and the Wound Evaluation Score
1 secondary outcome
Satisfaction score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
- Background: PubMed 9660284Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6. doi: 10.1111/j.1553-2712.1998.tb02465.x.
Related trials for Facial Lacerations
Active, not recruiting
Will a Hands on Technique Applied to the Face Increase the Tear Production in Participants
Increased Production of Tears
Not yet recruiting
Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection
Corneal Injury, Exposure Keratopathy
Not yet recruiting
Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations
Facial Laceration
Recruiting
Acne Face Wash for Reducing the Contamination Rate in Arthroscopic Rotator Cuff Repair Surgery
Rotator Cuff Tears of the Shoulder
Enrolling by invitationObservational study
Multi-Institutional IMPACT Validation
Facial Injuries, Mandible Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Lacerations, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01514084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.