Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828810
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-04-12
Brief Title:
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee - A Vanguard Randomized Controlled Registry Trial CLEAN Joint Trial
Status:
RECRUITING
Status Verified Date:
2023-04
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:
CLEANJoint
Brief Summary:
The goal of this clinical trial is to compare two types of solutions chlorhexidine gluconate-alcohol solution or povidone-iodine solution that help eliminate harmful bacteria on the skin at the time of surgery
The main outcome of interest is
the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery
Participants will be contacted at two time points after surgery to complete a 5-minute survey after 30 days and after 1 year
If you decide to participate you will be randomly assigned like flipping a coin by a computer to one of the possible interventions You will be told which group you have been assigned to
The main outcome of interest is
the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery
Participants will be contacted at two time points after surgery to complete a 5-minute survey after 30 days and after 1 year
If you decide to participate you will be randomly assigned like flipping a coin by a computer to one of the possible interventions You will be told which group you have been assigned to
Detailed Description:
In this trial participants will be assigned randomly to have their surgical skin site prepared for surgery with either chlorhexidine gluconate-alcohol solution or povidone-iodine solution These are two types of solutions that have antiseptic properties which means they help eliminate harmful bacteria on the skin at the time of surgery and therefore reduce the risk of infection Surgeons routinely use either chlorhexidine-based or iodine-based skin preparation solutions at the time of surgery to sterilize the surgical area However we dont know which one works best for patients having revision joint replacement surgery There is a small chance of having an allergic reaction to the chlorhexidine or iodine but there is no additional risk by participating in this study as these skin preparation solutions are routinely used in practice
The main outcome of interest is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery Other key outcomes are surgical site infection mortality and readmission to hospital Participants will be contacted 30 days after surgery to complete a survey online by phone or in person which will take approximately 5 minutes to complete All other outcome data will be collected by phone call health records routine hospital monitoring or electronic registry data at thirty days and one year after surgery
You may choose to participate in this trial or not If you decide to participate you will be randomly assigned like flipping a coin by a computer to one of the possible interventions You will be told which group you have been assigned to Participating in this program is your choice ie is voluntary You have the right to choose not to participate or to stop participating in this program at any time Your decision will not affect the care you receive at this time or in the future As part of this program we will use data that is already routinely collected from your hospital stay for administrative and quality-improvement purposes We will collect your OHIP number to securely link the records we collect to other databases already collected We will also collect your first and last name email address and phone number for follow-up survey purposes The person conducting this study and other study staff will keep the information they see or receive about you confidential Your de-identified study information will be kept in a secure and confidential location and then destroyed according to institutional policy You will not be paid for taking part in this study and there will be no costs associated with participation If you agree to take part there may or may not be any direct benefit to you You will receive a Research Study Information Sheet for your reference The Research Ethics Board that oversees the ethical conduct of this study may review your relevant study records for audit purposes
The main outcome of interest is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery Other key outcomes are surgical site infection mortality and readmission to hospital Participants will be contacted 30 days after surgery to complete a survey online by phone or in person which will take approximately 5 minutes to complete All other outcome data will be collected by phone call health records routine hospital monitoring or electronic registry data at thirty days and one year after surgery
You may choose to participate in this trial or not If you decide to participate you will be randomly assigned like flipping a coin by a computer to one of the possible interventions You will be told which group you have been assigned to Participating in this program is your choice ie is voluntary You have the right to choose not to participate or to stop participating in this program at any time Your decision will not affect the care you receive at this time or in the future As part of this program we will use data that is already routinely collected from your hospital stay for administrative and quality-improvement purposes We will collect your OHIP number to securely link the records we collect to other databases already collected We will also collect your first and last name email address and phone number for follow-up survey purposes The person conducting this study and other study staff will keep the information they see or receive about you confidential Your de-identified study information will be kept in a secure and confidential location and then destroyed according to institutional policy You will not be paid for taking part in this study and there will be no costs associated with participation If you agree to take part there may or may not be any direct benefit to you You will receive a Research Study Information Sheet for your reference The Research Ethics Board that oversees the ethical conduct of this study may review your relevant study records for audit purposes
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