- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Minnesota
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Twin Cities, Minnesota, Forenede Stater
- Children's Hospitals and Clinics of Minnesota
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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PEM group
Patients whose lacerations have been repaired by PEM trained physicians.
|
|
GP group
Patients whose lacerations have been repaired by general pediatricians.
|
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PNP group
Patients whose lacerations have been repaired by PNPs.
|
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RN group
Patients whose lacerations have been repaired by suture RNs.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cosmetic outcome
Tidsramme: 6 months
|
Cosmetic Visual Analog Score and the Wound Evaluation Score
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Satisfaction score
Tidsramme: 6 months
|
Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"
|
6 months
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1108-081
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Kliniske forsøg med Facial Lacerations
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Kanuni Sultan Suleyman Training and Research HospitalAfsluttetPerineal Laceration involverer hud | Levering; TraumaKalkun
-
Medtronic - MITGAfsluttetPerineal Laceration ReparationForenede Stater
-
Clinical Research Centre, MalaysiaAfsluttetPerineal tåre | Perineal Laceration (Obstetrisk)
-
Massachusetts General HospitalAfsluttetPerineal tåre | Levering; Trauma | Perineal LacerationForenede Stater
-
Saint-Joseph UniversityAfsluttet
-
Bispebjerg HospitalRekrutteringMuskelbelastning, underben | Muskelspændt lår | Akillessenen; Laceration | Fedt degenerationDanmark
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S.K. Lerik General HospitalAfsluttetSår og skader | Sårheling | Laceration Ansigt | Laceration Arm | Skæring af benIndonesien
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Cairo UniversityIkke rekrutterer endnu
-
Azienda Sanitaria-Universitaria Integrata di UdineRekruttering
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Université de SherbrookeAgence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-JeanRekruttering