Laceration Clinical Trial
Official title:
A Randomized, Controlled, Post-market Clinical Investigation to Evaluate Zip Surgical Skin Closure Device in Comparison of Using Standard of Care Sutures for Laceration Repair in Pediatrics and Adults in an Accident and Emergency Department
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. The investigation is designed to evaluate the time and cost savings and the satisfaction and outcomes of the Zip device compared to conventional sutures. The subjects will be randomly assigned at a 1:1 ratio to either the Zip Surgical Skin Closure Device group or the Standard of Care sutures group. The investigation consists of one screening/baseline visits at day 0 where the subject will be treated with either the Zip device or sutures, and thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be removed prior the first follow up call day 10. The duration of the investigation is estimated to 5 months, including a 4-month recruitment period and 1-month follow up period.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03280628 -
Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches
|
N/A | |
Completed |
NCT00451724 -
Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
|
Phase 2 | |
Completed |
NCT05240248 -
Optilene® Suture Material for Dermal Sutures
|
||
Completed |
NCT02882256 -
Video Discharge Instructions (VDI) as Adjuncts to Written Discharge Instructions in the Emergency Department
|
N/A | |
Active, not recruiting |
NCT02168439 -
Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
|
Phase 4 | |
Completed |
NCT03080467 -
Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive
|
||
Recruiting |
NCT05225714 -
Dermal Wound Closure Using Silkam®
|
||
Active, not recruiting |
NCT01911351 -
Nitrous Oxide Use in Minor Procedures
|
N/A | |
Suspended |
NCT01268670 -
The Addition of Oral Analgesics to LET During Laceration Repair
|
N/A | |
Recruiting |
NCT04557761 -
Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
|
N/A | |
Completed |
NCT05812352 -
Supporting Laypeople Addressing Prehospital Hemorrhage Study
|
N/A | |
Completed |
NCT00834730 -
Comparison of N2O Inhalation and Ketamine in Pediatric PSA
|
Phase 4 | |
Completed |
NCT03053947 -
Pain Free Laceration Repairs Using Intra-nasal Ketamine
|
Phase 2 | |
Recruiting |
NCT03681717 -
Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair
|
N/A | |
Completed |
NCT03071601 -
Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department
|
Phase 4 | |
Completed |
NCT06370910 -
Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction
|
N/A | |
Completed |
NCT05148390 -
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
|
||
Not yet recruiting |
NCT06217081 -
3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and Incisions
|
N/A | |
Withdrawn |
NCT03499002 -
Teaching Medical Students How to Suture: Standard Simulation vs in Situ
|
N/A |