Last reviewed · How we verify
Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches
NA trial testing Absorbable Sutures in Laceration in 55 participants. Terminated before completion.
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 23 September 2017 |
| Primary completion | 1 February 2021 |
| Estimated completion | 1 February 2021 |
| Sites | 1 location across United States |
Vanderbilt University Medical Center
Under 18, any sex, with Laceration. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "worst scar" and a score of 100 corresponding to "best scar"
| Group | Value | 95% CI |
|---|---|---|
| Absorbable Sutures | 64.00 | 51.00 – 76.00 |
| Steri-Strips | 54.00 | 35.50 – 66.75 |
| Dermabond | 48.50 | 29.50 – 78.75 |
Parents will each be asked to score how much pain they felt the patient experienced using a 100 mm Visual Analogue Scale with a score of 0 corresponding to "No pain" and a score of 100 corresponding to "Terrible pain."
| Group | Value | 95% CI |
|---|---|---|
| Absorbable Sutures | 17.00 | 1.50 – 51.50 |
| Steri-Strips | 22.00 | 9.00 – 28.00 |
| Dermabond | 11.00 | 3.00 – 24.50 |
Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with "100" meaning completely satisfied and "0" meaning not at all satisfied
| Group | Value | 95% CI |
|---|---|---|
| Absorbable Sutures | 89.50 | 45.25 – 98.50 |
| Steri-Strips | 92.00 | 83.00 – 100.00 |
| Dermabond | 94.00 | 71.25 – 100.00 |
Parents will be asked to rate how likely they would be to recommend the closure method used for their child using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "Extremely unlikely" and a score of 100 corresponding to "Extremely likely"
| Group | Value | 95% CI |
|---|---|---|
| Absorbable Sutures | 99.50 | 88.00 – 100.00 |
| Steri-Strips | 99.00 | 95.00 – 100.00 |
| Dermabond | 99.50 | 94.50 – 100.00 |
Parents will be asked by phone at 3 months if there were any complications with their child's cut (infection, opening of the wound, etc.). Investigators will count the number of complications reported.
| Group | Value | 95% CI |
|---|---|---|
| Absorbable Sutures | 0 | |
| Steri-Strips | 0 | |
| Dermabond | 0 |
Parents will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "worst scar" and a score of 100 corresponding to "best scar".
| Group | Value | 95% CI |
|---|---|---|
| Absorbable Sutures | 70.50 | 59.75 – 76.75 |
| Steri-Strips | 67.00 | 55.00 – 78.00 |
| Dermabond | 85.00 | 73.00 – 90.00 |
Plastic Surgeons will record if a scar appears to have "train tracks" (or small dots on either side of a scar, all along the scar, usually caused by stitches) as they are rating each photo of the scar at 3 months post-closure. Surgeons will answer "yes" or "no".
| Group | Value | 95% CI |
|---|---|---|
| Absorbable Sutures | 4 | |
| Steri-Strips | 4 | |
| Dermabond | 3 |
There are several methods of closing a skin cut: stitches, skin glue, and medical tape. Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s) and medical tape (invented in the 1960s) are two newer methods to close skin cuts. The purpose of this study is to find out which method (stitches, skin glue, or medical tape) of closing skin cuts results in the least amount of scarring. Other things the investigators will be looking at are which method is the cheapest, which causes the least pain, which requires the least amount of sedation, and which method patients and parents like the best.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03280628.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing