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

NCT ID: NCT03321721

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-13
• Study Completion Date: 2019-05-31

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.

Conditions

Laceration Repair, Children; Hand Injuries; Foot Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conservative

patient fulfilling entry criteria will be randomized to the conservative arm - no suturing

Group Type: NO_INTERVENTION

No interventions assigned to this group

suture

patient fulfilling entry criteria will be randomized to the suture arm for repair with nylon suture material

Group Type: ACTIVE_COMPARATOR

Suture for wound repair

Intervention Type: PROCEDURE

Repair of wound with suture

Suture for wound repair

Intervention Type: DEVICE

Repair of wound with suture

Interventions

Suture for wound repair

Repair of wound with suture

Intervention Type: PROCEDURE

Suture for wound repair

Repair of wound with suture

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Trevor Tredway, MD

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

cardinal glennon children's hospital / Division of Emergency Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB 26912

Identifier Type: -

Identifier Source: org_study_id