Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504992
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Powdered Intrawound Vancomycin in Open Fractures Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Powdered Intrawound Vancomycin in Open Fractures a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
PIVOT
Brief Summary:
The purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive operative fixation of the fracture
Detailed Description:
Primary Objective
To evaluate the effect of intra-operative intrawound topical vancomycin powder on open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive fixation of the fracture on deep surgical site infection defined as a post-operative surgical infection requiring return to the operating room for irrigation and debridement with or without hardware removalrevision within the first six months following surgery
Secondary Objectives
To evaluate the effect of intra-operative intrawound topical vancomycin powder on superficial surgical site infection defined as a post-operative infection that required antibiotic treatment but no return to the operating room readmissions to hospital for post-operative surgical infection deep or superficial and hardware failure defined as hardware loosening loss of fixation hardware fracture or hardware migration visualized either on imaging or found intra-operatively
To evaluate differences in microbe characteristics in cultures taken intra-operatively in the take-back irrigation and debridement surgery in patients with deep surgical site infection
To evaluate if the effect of intra-operative intrawound topical vancomycin powder changes based on fracture and patient characteristics upper extremity versus lower extremity Gustilo Classification patients with documented Methicillin-resistant Staphylococcus aureus MRSA colonization and mechanism of injury
To evaluate if certain fracture and patient characteristics upper extremity versus lower extremity Gustilo Classification patients with documented Methicillin-resistant Staphylococcus aureus MRSA colonization and by their mechanism of injury increases the risk of infection in both the treatment and control group
To evaluate the effect of intra-operative intrawound topical vancomycin powder on open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive fixation of the fracture on deep surgical site infection defined as a post-operative surgical infection requiring return to the operating room for irrigation and debridement with or without hardware removalrevision within the first six months following surgery
Secondary Objectives
To evaluate the effect of intra-operative intrawound topical vancomycin powder on superficial surgical site infection defined as a post-operative infection that required antibiotic treatment but no return to the operating room readmissions to hospital for post-operative surgical infection deep or superficial and hardware failure defined as hardware loosening loss of fixation hardware fracture or hardware migration visualized either on imaging or found intra-operatively
To evaluate differences in microbe characteristics in cultures taken intra-operatively in the take-back irrigation and debridement surgery in patients with deep surgical site infection
To evaluate if the effect of intra-operative intrawound topical vancomycin powder changes based on fracture and patient characteristics upper extremity versus lower extremity Gustilo Classification patients with documented Methicillin-resistant Staphylococcus aureus MRSA colonization and mechanism of injury
To evaluate if certain fracture and patient characteristics upper extremity versus lower extremity Gustilo Classification patients with documented Methicillin-resistant Staphylococcus aureus MRSA colonization and by their mechanism of injury increases the risk of infection in both the treatment and control group
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