Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair

Stopped early · Not applicable

Conditions studied: Laceration Repair, Children, Hand Injuries, Foot Injuries

In brief

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.

Key facts

Study ID

NCT03321721

Run by

St. Louis University

People needed

26

Starts

2014-04-13

Expected to finish

2019-05-01

Last updated by the study team

2020-10-09

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• cardinal glennon children's hospital / Division of Emergency Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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