Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair
16. september 2020 oppdatert av: Trevor Tredway, MD, St. Louis University
Conservative Versus Suture Repair of Hand and Feet Lacerations in Children
Hand and feet lacerations are common in children with repair often requiring conscious sedation and needle sticks for repair.
Growing evidence in adults reveal that many of these small lacerations do quite well cosmetically without intervention.
This randomized controlled trial will evaluated the cosmetic outcome at 4 months in two groups of children with hand or feet lacerations <2 cm comparing suturing vs conservative wound management.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of this study is to compare outcomes of 2 repair methods in simple (<2cm) hand and feet lacerations in the pediatric population (2-17 yrs).
Our hypothesis is that there is no statistical difference in cosmetic outcomes between suture repair and non-repair of these injuries.
This study has been performed in the adult population, but has not yet been done in children.
The researchers would like to be the first to show that conservative repair can be done in our pediatric population.
The suture group will have their injuries repaired with non-absorbable sutures (nylon) which remain the gold standard in cosmetic repair of hands and feet.
The conservative group will have identical cleaning and preparation of the wound, but the laceration will be covered with antibiotic ointment and sterile gauze without repair.
Secondary outcome measure include patient satisfaction, infection rates, pain during repair, time of initial ED visit stay, and cost of supplies used in repair.
Our patients will return in 10 -14 days for follow up and in 4 months for evaluation of the wound and for digital pictures to be taken of the wound.
Wounds and scars will be evaluated at both 10 -14 days and 4 months by both the researchers and the parents or care givers.
A satisfaction survey will be administered to the parent or guardian.
At 3-4 months, digital photographs of the healing lacerations will be graded for appearance by clinicians blinded to the repair method.
The initial visit will be billed to their insurance and the follow-up visits will be free.
Studietype
Intervensjonell
Registrering (Faktiske)
26
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Missouri
-
Saint Louis, Missouri, Forente stater, 63104
- cardinal glennon children's hospital / Division of Emergency Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
2 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Any English-speaking child, 2 to 17 years of age that presents to the emergency department at Cardinal Glennon Children's Medical Center with a hand or foot laceration less than or equal to 2 cm is eligible for the study.
Exclusion Criteria:
- Patients will be excluded if their laceration is greater than 2 cm, have irregular borders or are, deeper than 0.5 cm.
- Wounds that are the result of a mammalian bite,
- Wounds more than minimally contaminated on visual inspection or are more than 8 hours old.
- Wounds associated with an open fracture, involve a partial amputation or involve a puncture wound.
- Wounds that involve the nailbed or a fingernail avulsion will be excluded.
- Patients with confirmed or suspected retained foreign bodies in the wound would also be excluded.
- Patients will also be excluded if hemostasis could not be attained after 15 minutes of pressure.
- Patients with complex lacerations who need plastic surgery or other sub-specialty repair will be excluded.
- Complex lacerations include: associated or suspected neurovascular, tendon, ligament, or bone injury, need for deep/multi-layer sutures will be excluded.
- Patients with known or suspected immunodeficiency, bleeding or clotting disorders, pregnancy, diabetes, renal dysfunction, or allergic reaction to local anesthesia are also excluded.
- Patients with a history of anticoagulant or chronic steroid use in the last year. Chronic steroid use is defined by use of steroids (PO, IV, IM, or topical) for more than 14 consecutive days, for more than 3 separate courses per year will be excluded.
- Foster children will also be excluded, due to complications regarding custody, consent, and follow-up issues.
- Patients with allergies to topical anesthetics solution will be excluded from the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: conservative
patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
|
|
|
Aktiv komparator: suture
patient fulfilling entry criteria will be randomized to the suture arm for repair with nylon suture material
|
Repair of wound with suture
Repair of wound with suture
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Tidsramme: 4 months
|
Randomized, parallel group study will compare cosmetic outcome by digital picture by blinded evaluators at 4 months post enrollment. The digital pictures of the laceration repairs were scored using a previously validated Visual Analogue Scale (VAS). The VAS scale is a 100-mm continuous line that is marked at the right end with "best appearance/scar"(score 100), and on the left end with "worst appearance/scar" (score 0). |
4 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair
Tidsramme: 10-14 days
|
Wound healing by visual inspection at the first follow up visit. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives. The outcome measure data is reported as the number of participants without the presence of "wound infection" or "wound dehiscence". |
10-14 days
|
|
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Tidsramme: 10-14 days
|
Infection rate by visual inspection.
The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
|
10-14 days
|
|
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Tidsramme: 10-14 days
|
Rate of wound dehiscence by visual inspection.
The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
|
10-14 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. april 2014
Primær fullføring (Faktiske)
1. mai 2019
Studiet fullført (Faktiske)
1. mai 2019
Datoer for studieregistrering
Først innsendt
22. september 2017
Først innsendt som oppfylte QC-kriteriene
25. oktober 2017
Først lagt ut (Faktiske)
26. oktober 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. september 2020
Sist bekreftet
1. september 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB 26912
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
if other facilities are performing similar studies would be happy to participate
IPD-delingstidsramme
7/19
Tilgangskriterier for IPD-deling
By Appointment
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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