Foot Injuries, Hand Injuries, Laceration Repair, Children
Conditions
Keywords
hand, feet lacerations, children, conservative management
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.
Interventions
PROCEDURESuture for wound repair
Repair of wound with suture
Sponsors
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
patients are randomized after informed consent evaluation of cosmetic outcome at 4m is blinded to researchers
Intervention model description
randomized, parallel group, comparative study
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | 4 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair | 10-14 days | 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 | 10-14 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conservative Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing | 4 |
| Suture (Absorbable) Patient fulfilling entry criteria will be randomized to the absorbable suture arm for repair with absorbable suture material | 12 |
| Suture (Non-Absorbable) Patient fulfilling entry criteria will be randomized to the non-absorbable suture arm for repair with non-absorbable suture material | 10 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 8 | 11 |
Baseline characteristics
| Characteristic | Conservative | Suture (Non-Absorbable) | Total | Suture (Absorbable) |
|---|---|---|---|---|
| Age, Continuous | 13 years STANDARD_DEVIATION 1 | 8.6 years STANDARD_DEVIATION 5.65 | 9.8 years STANDARD_DEVIATION 5.04 | 10.3 years STANDARD_DEVIATION 4.61 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 4 Participants | 10 Participants | 26 Participants | 12 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 19 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 4 | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 4 | 0 / 12 | 0 / 10 |
Outcome results
Primary
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).
Time frame: 4 months
Population: No participants in the conservative arm/group of the study completed the study protocol. Only 1 participant in the absorbable suture arm/group of the study and 2 participants in the non-absorbable arm/group of the study completed the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture (Absorbable) | Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | 60 Score on a scale (100-mm VAS) | — |
| Suture (Non-Absorbable) | Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | 100 Score on a scale (100-mm VAS) | Standard Deviation 0 |
Secondary
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.
Time frame: 10-14 days
Population: No participants in the conservative arm/group completed the study protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture (Absorbable) | Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | 0 Participants |
| Suture (Non-Absorbable) | Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | 0 Participants |
Secondary
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.
Time frame: 10-14 days
Population: No participants in the conservative arm/group completed the study protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture (Absorbable) | Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | 0 Participants |
| Suture (Non-Absorbable) | Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | 0 Participants |
Secondary
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.
Time frame: 10-14 days
Population: No participants in the conservative arm/group completed the study. 3 patients in the absorbable arm and 4 patients in the non-absorbable arm completed the first part and were present for their first follow up.1 of the 3 absorbable arm patients completed the entire study and 2 of the 4 non-absorbable arm patients completed the entire study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture (Absorbable) | Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair | 0 Participants |
| Suture (Non-Absorbable) | Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair | 0 Participants |