Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair
16 september 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
26
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Missouri
-
Saint Louis, Missouri, Förenta staterna, 63104
- cardinal glennon children's hospital / Division of Emergency Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
2 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 april 2014
Primärt slutförande (Faktisk)
1 maj 2019
Avslutad studie (Faktisk)
1 maj 2019
Studieregistreringsdatum
Först inskickad
22 september 2017
Först inskickad som uppfyllde QC-kriterierna
25 oktober 2017
Första postat (Faktisk)
26 oktober 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 oktober 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 september 2020
Senast verifierad
1 september 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB 26912
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
if other facilities are performing similar studies would be happy to participate
Tidsram för IPD-delning
7/19
Kriterier för IPD Sharing Access
By Appointment
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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