Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-22
Brief Title:
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures A Multicenter Randomized Controlled Trial
Sponsor:
Major Extremity Trauma Research Consortium
Organization:
Major Extremity Trauma Research Consortium
Study Overview
Official Title:
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures A Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iVAC
Brief Summary:
This is a multi-center pragmatic parallel arm randomized controlled trial RCT of 352 patients with high-risk open or closed tibial plateau fracture high-risk open or closed tibial pilon fracture or open tibial shaft fracture with incision 3cm Eligible participants will be randomized to receive either incisional negative pressure wound therapy NPWT or a non-suction standard-of-care wound dressing for their definitive wound management The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization The secondary outcomes will independently assess the components of the primary outcome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None