NCT03321721

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

Conservative Versus Suture Repair of Hand and Feet Lacerations in Children

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Laceration Repair, Children
• Hand Injuries
• Foot Injuries

Interventions

Type	Name	Description
PROCEDURE	Suture for wound repair	Repair of wound with suture
DEVICE	Suture for wound repair	Repair of wound with suture

Timeline

• Start date: 2014-04-13
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2017-10-26
• Last updated: 2020-10-09
• Results posted: 2020-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study