An interventional study of Suture for wound repair and Suture for wound repair in Laceration Repair, Children, Hand Injuries and Foot Injuries, sponsored by St. Louis University. Terminated at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by St. Louis University · Not applicable, Interventional, and Treatment
Among 27 studies in Hand Injuries with a site in United States — 8 open to participants now, 8 under way, none of them phase 3. Hand Injuries · United States.
Among the 27 studies in Hand Injuries with a site in United States, this one is the 15th largest by enrollment of the 26 interventional ones that give a count, is one of 4 that started in 2014, is one of 21 with no phase, and was the 8th registered.
122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.
This study's enrollment of 26 is below the median of 55 across 97 interventional studies indexed under Hand Injuries.
Browse Hand Injuries studies →8 of the 27 studies in Hand Injuries with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 26 Hand Injuries studies recruiting now, 14 (54%) set no upper age limit and 10 (38%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 2 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 1 · Phase 4 2
First in 2010; this study’s year is marked. 4 started in 2014.
Median enrollment 30 across the 26 interventional studies, 60 across the 1 observational. Of the 15 that completed or were terminated, 3 (20%) have results posted.
None of the 27 has an industry lead sponsor. The 10 most frequent:
St. Louis University is the lead sponsor of 156 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
St. Louis University has 1 study filed under Hand Injuries — fewer than ten, so there is no comparison to draw.
2 of the studies in Hand Injuries with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05846399University of Missouri-ColumbiaCAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE) | 2027-07-01 |
| NCT07492797Mississippi State UniversityAccessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring | 2027-09-14 |
Among the 27 studies in Hand Injuries with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Suture for wound repair · Device: Suture for wound repair
Repair of wound with suture
Repair of wound with suture
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
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
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
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
| Milestone | Conservative | Suture-Non Absorbable | Suture-Absorbable |
|---|---|---|---|
| Started | 4 | 10 | 12 |
| Completed | 0 | 2 | 1 |
| Not completed | 4 | 8 | 11 |
| Withdrew: Lost to follow-up | 4 | 8 | 11 |
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).
| Score on a scale (100-mm VAS) | Conservative | Suture (Absorbable) | Suture (Non-Absorbable) |
|---|---|---|---|
| Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | — | 60 | 100 ± 0 |
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".
| Participants | Conservative | Suture (Absorbable) | Suture (Non-Absorbable) |
|---|---|---|---|
| Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair | — | 0 | 0 |
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.
| Participants | Conservative | Suture (Absorbable) | Suture (Non-Absorbable) |
|---|---|---|---|
| Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | — | 0 | 0 |
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.
| Participants | Conservative | Suture (Absorbable) | Suture (Non-Absorbable) |
|---|---|---|---|
| Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair | — | 0 | 0 |
Collected over After patients completed their final follow up visit, they were instructed to contact the PI with any concerns about the laceration repair/wound for the time period of 1 year from date of initial repair.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conservative | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Suture (Absorbable) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Suture (Non-Absorbable) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Conservative | Suture (Absorbable) | Suture (Non-Absorbable) | Total |
|---|---|---|---|---|
| Mean | 13 ± 1 | 10.3 ± 4.61 | 8.6 ± 5.65 | 9.8 ± 5.04 |
| Sex: Female, Male(Participants) | Conservative | Suture (Absorbable) | Suture (Non-Absorbable) | Total |
|---|---|---|---|---|
| Female | 0 | 4 | 3 | 7 |
| Male | 4 | 8 | 7 | 19 |
| Race and Ethnicity Not Collected(Participants) | Conservative | Suture (Absorbable) | Suture (Non-Absorbable) | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | Conservative | Suture (Absorbable) | Suture (Non-Absorbable) | Total |
|---|---|---|---|---|
| United States | 4 | 12 | 10 | 26 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — if other facilities are performing similar studies would be happy to participate
Supporting information: Study protocol, Informed consent form
Time frame: 7/19
Access criteria: By Appointment
Ran from Apr 2014 to primary completion in May 2019, 61 months.
Results were first posted in Oct 2020, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.