Ignite Creation Date:
2024-05-06 @ 2:15 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02006511
Status:
WITHDRAWN
Last Update Posted:
2023-05-06
First Post:
2013-11-13
Brief Title:
Incisional Negative Pressure Dressing on Clean Closed Groin Incisions
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients
Status:
WITHDRAWN
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was never performed and closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Wound complications associated with surgical incisions range from minor to life threatening Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications Perigraft infections in groin wounds can be devastating Even superficial wounds can progress to deep wounds resulting in graft infection need for explantation and sepsis or amputation requirement Negative pressure wound therapy has had favorable results on closed wounds in trauma populations Similarly negative pressure wound therapy has had positive benefits in closed incisions such as sternal wounds following cardiac surgery As a result the PrevenaTM Incision Management SystemIMS was developed to allow easier application of negative pressure therapy to closed wounds Application of the PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure VAC therapy with the added benefits of protecting the wound from contamination and bolstering the wound edges for better approximation and consequently better aesthetic outcome However no comparison between negative pressure therapy as a dressing and standard wound dressings exists
The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery
The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery
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