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

NCT03321721 | Terminated Results FDA Device

• 1 other identifier: IRB 26912
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Laceration Repair, Children; Hand Injuries; Foot Injuries

Keywords

hand; feet lacerations; children; conservative management

Outcome Measures

Primary Outcomes (1)

• Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair

  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

Secondary Outcomes (3)

• Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair

  10-14 days

• Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair

  10-14 days

• Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair

  10-14 days

Study Arms (2)

conservative

NO INTERVENTION

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

suture

ACTIVE COMPARATOR

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

Procedure: Suture for wound repair; Device: Suture for wound repair

Interventions

Suture for wound repair PROCEDURE

Repair of wound with suture

suture

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

cardinal glennon children's hospital / Division of Emergency Medicine

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Hand Injuries; Foot Injuries

Interventions

Sutures; Wound Healing

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Regeneration; Biological Phenomena

Results Point of Contact

• Title: Dr. Trevor L. Tredway
• Organization: St. Louis University School of Medicine

trevor.tredway@health.slu.edu

314-577-5630

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: patients are randomized after informed consent evaluation of cosmetic outcome at 4m is blinded to researchers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: randomized, parallel group, comparative study

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 26, 2017
• Study Start: April 13, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 7/19
• Access Criteria: By Appointment

Locations

US (1)