Clinical trial NCT03321721: Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair
Official title: Conservative Versus Suture Repair of Hand and Feet Lacerations in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laceration Repair, Children
Hand Injuries
Foot Injuries
Keywords: hand
feet lacerations
children
conservative management
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, parallel group, comparative study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
timeFrame: 4 months
Secondary outcomes:
measure: Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair
timeFrame: 10-14 days
measure: Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
timeFrame: 10-14 days
measure: Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
timeFrame: 10-14 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: cardinal glennon children's hospital / Division of Emergency Medicine
state: Missouri
Study officials:
References: