Laceration Repair, ChildrenNCT03321721
Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair
A study testing Suture for wound repair in people with Laceration Repair, Children and Hand Injuries, run by St. Louis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Laceration Repair, Children, Hand Injuries, Foot Injuries
- What is being tested?
- Suture for wound repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2014to May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
cardinal glennon children's hospital / Division of Emergency Medicine
St Louis, Missouri, 63104
About this study
Official title: 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.
Read the 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.
- Conditions
- Laceration Repair, Children, Hand Injuries, Foot Injuries
- Being tested
- Suture for wound repair
- Keywords
- hand, feet lacerations, children, conservative management
- Medical subject headings
- Hand Injuries, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture for wound repairProcedure or surgery
Repair of wound with suture
Suture for wound repairDevice
Repair of wound with suture
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Suture for wound repair; Device: Suture for wound repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
Secondary outcomes (3)
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".
Measured: 10-14 days
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.
Measured: 10-14 days
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.
Measured: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start13 Apr 2014
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: lack of recruitment and follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laceration Repair, ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, parallel group, comparative study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trevor Tredway, MD, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321721
- Sponsor's protocol ID
- IRB 26912
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2017
- Last updated
- 9 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: if other facilities are performing similar studies would be happy to participate
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Suture Repair of Hand and Feet Lacerations in Children
- ClinicalTrials.gov ID
- NCT03321721
- Acronym / sponsor ID
- IRB 26912
- Conditions
- Laceration Repair, Children, Hand Injuries, Foot Injuries
- Keywords
- hand, feet lacerations, children, conservative management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment and follow up
- Enrolment
- 26 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 13 Apr 2014 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, parallel group, comparative study
| Arm | Type | Receives |
|---|---|---|
| conservative | No intervention | –patient fulfilling entry criteria will be randomized to the conservative arm - no suturing |
| suture | Active comparator | Procedure: Suture for wound repair, Device: Suture for wound repairpatient fulfilling entry criteria will be randomized to the suture arm for repair with nylon suture material |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture for wound repairRepair of wound with suture | Procedure or surgery | suture |
| Suture for wound repairRepair of wound with suture | Device | suture |
Primary outcome
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. 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).
3 secondary outcomes
Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair
Time frame: 10-14 days
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Time frame: 10-14 days
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
Time frame: 10-14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. if other facilities are performing similar studies would be happy to participate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture for wound repair in people with Laceration Repair, Children and Hand Injuries, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.