Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03132246
Status:
COMPLETED
Last Update Posted:
2020-05-15
First Post:
2017-04-07
Brief Title:
MICRO Study Detecting Bacterial Infections Related to Orthopaedic Surgical Implants
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Early Determination of Biofilm Formation on Orthopaedic Devices
Status:
COMPLETED
Status Verified Date:
2020-05
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:
MICRO
Brief Summary:
A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted The investigators will be collecting between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm growth Patients may be infected or non-infected at the time of blood draw they will be selected at random for purposes of this study All patients will be followed as standard of care by their treating physician for all their follow up visits
Detailed Description:
Surgical site infection in the orthopaedic surgery population is a significant public health issue Wound infections result in both increased length of hospital stay and total cost of care
Surgical site infection SSI is the most common preventable adverse outcome after a major operation The economic costs to the US healthcare system are enormous estimated to be in excess of 18 billion per year For patients who develop an SSI the cost may be even higher with length of stay and risk of death doubled Thus the benefits of any intervention decreasing the risk of SSI are very tangible
A biofilm is a layer of bacteria that adheres to a surface in Orthopaedics this often means adherence to implanted metal after fracture surgery The test that has been designed by one of the investigators on the study has been shown in an animal model to detect the formation of a biofilm up to 1 month prior to clinical detection Having a blood assay such as this would allow earlier antibiotics and potentially prevent the need for further surgeries to remove metal implants and clean out the biofilm
Surgical site infection SSI is the most common preventable adverse outcome after a major operation The economic costs to the US healthcare system are enormous estimated to be in excess of 18 billion per year For patients who develop an SSI the cost may be even higher with length of stay and risk of death doubled Thus the benefits of any intervention decreasing the risk of SSI are very tangible
A biofilm is a layer of bacteria that adheres to a surface in Orthopaedics this often means adherence to implanted metal after fracture surgery The test that has been designed by one of the investigators on the study has been shown in an animal model to detect the formation of a biofilm up to 1 month prior to clinical detection Having a blood assay such as this would allow earlier antibiotics and potentially prevent the need for further surgeries to remove metal implants and clean out the biofilm
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