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



Status:Recruiting
Conditions:Hospital, Orthopedic, Podiatry
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:2 - 17
Updated:7/8/2018
Start Date:April 13, 2014
End Date:June 2020
Contact:albert nakanishi, MD
Email:nakanimk@slu.edu
Phone:314 577 5360

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Conservative Versus Suture Repair of Hand and Feet Lacerations in Children

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.

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.

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.
We found this trial at
1
site
1465 South Grand Boulevard
Saint Louis, Missouri 63104
Phone: 314-577-5360
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mi
from
Saint Louis, MO
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