Back to resultsCosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair
Primary Purpose
Laceration Repair, Children, Hand Injuries, Foot Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suture for wound repair
Suture for wound repair
Sponsored by
About this trial
This is an interventional treatment trial for Laceration Repair, Children focused on measuring hand, feet lacerations, children, conservative management
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.
Sites / Locations
- cardinal glennon children's hospital / Division of Emergency Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
conservative
suture
Arm Description
patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
patient fulfilling entry criteria will be randomized to the suture arm for repair with nylon suture material
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair
Wound healing by visual inspection at the first follow up visit. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
The outcome measure data is reported as the number of participants without the presence of "wound infection" or "wound dehiscence".
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Infection rate by visual inspection. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Rate of wound dehiscence by visual inspection. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
Full Information
NCT ID
NCT03321721
First Posted
September 22, 2017
Last Updated
September 16, 2020
Sponsor
St. Louis University
1. Study Identification
Unique Protocol Identification Number
NCT03321721
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment and follow up
Study Start Date
April 13, 2014 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration Repair, Children, Hand Injuries, Foot Injuries
Keywords
hand, feet lacerations, children, conservative management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, parallel group, comparative study
Masking
Outcomes Assessor
Masking Description
patients are randomized after informed consent evaluation of cosmetic outcome at 4m is blinded to researchers
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conservative
Arm Type
No Intervention
Arm Description
patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
Arm Title
suture
Arm Type
Active Comparator
Arm Description
patient fulfilling entry criteria will be randomized to the suture arm for repair with nylon suture material
Intervention Type
Procedure
Intervention Name(s)
Suture for wound repair
Intervention Description
Repair of wound with suture
Intervention Type
Device
Intervention Name(s)
Suture for wound repair
Intervention Description
Repair of wound with suture
Primary Outcome Measure Information:
Title
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Description
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).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair
Description
Wound healing by visual inspection at the first follow up visit. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
The outcome measure data is reported as the number of participants without the presence of "wound infection" or "wound dehiscence".
Time Frame
10-14 days
Title
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Description
Infection rate by visual inspection. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
Time Frame
10-14 days
Title
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Description
Rate of wound dehiscence by visual inspection. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
Time Frame
10-14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
cardinal glennon children's hospital / Division of Emergency Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
if other facilities are performing similar studies would be happy to participate
IPD Sharing Time Frame
7/19
IPD Sharing Access Criteria
By Appointment
Learn more about this trial
Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair
We'll reach out to this number within 24 hrs