Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586814
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SvS
Brief Summary:
This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries The primary objectives are to determine if enrollment randomization and compliance are feasible and to refine data collection methods Patients 18 years of age with closed fractures of the tibial plateau tibial pilon patella and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation If enrolled they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples Patient follow up will be standard of care besides answering PROMIS surveys
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None