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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03321721
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : July 6, 2018
Information provided by (Responsible Party):
Albert Nakanishi, MD, St. Louis University

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.

Condition or disease Intervention/treatment Phase
Laceration Repair, Children Hand Injuries Foot Injuries Other: Suture (nylon) for wound repair Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, parallel group, comparative study
Masking: Single (Outcomes Assessor)
Masking Description: patients are randomized after informed consent evaluation of cosmetic outcome at 4m is blinded to researchers
Primary Purpose: Treatment
Official Title: Conservative Versus Suture Repair of Hand and Feet Lacerations in Children
Actual Study Start Date : April 13, 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: conservative
patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
Active Comparator: suture
patient fulfilling entry criteria will be randomized to the suture arm for repair with nylon suture material
Other: Suture (nylon) for wound repair
suture of wound
Other Name: No suture wound repair

Primary Outcome Measures :
  1. Cosmetic outcome of hand and feet laceration in children : conservative vs suture repair [ Time Frame: 4 months ]
    randomized, parallel group study will compare cosmetic outcome by digital picture by blinded evaluators at 4 months post enrollment

Secondary Outcome Measures :
  1. Cosmetic outcome of hand and feet laceration in children : conservative vs suture repair [ Time Frame: 10-14 days ]
    wound healing by visual inspection

  2. Cosmetic outcome of hand and feet laceration in children : conservative vs suture repair [ Time Frame: 10-14 days ]
    infection rate by visual inspection

  3. Cosmetic outcome of hand and feet laceration in children : conservative vs suture repair [ Time Frame: 10-14 days ]
    rate of wound dehiscence by visual inspection

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03321721

Contact: albert nakanishi, MD 314 577 5360
Contact: trevor tredway, MD.PHD 314 577 5360

United States, Missouri
cardinal glennon children's hospital / Division of Emergency Medicine Recruiting
Saint Louis, Missouri, United States, 63104
Contact: albert nakanishi, MD    314-577-5360   
Contact: trevor tredway, MD, PHD    314 577 5360   
Sponsors and Collaborators
St. Louis University

Responsible Party: Albert Nakanishi, MD, Associate Professor of Pediatrics, St. Louis University Identifier: NCT03321721     History of Changes
Other Study ID Numbers: IRB 26912
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: if other facilities are performing similar studies would be happy to participate

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Albert Nakanishi, MD, St. Louis University:
feet lacerations
conservative management

Additional relevant MeSH terms:
Wounds and Injuries
Hand Injuries
Foot Injuries
Leg Injuries