Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628115
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Post Market Study of Cerament VG in Pedal Osteomyelitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post-market Study of Cerament VG in Foot Osteomyelitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Cerament 2
Brief Summary:
The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste The main question it aims to answer is
How does the bone infection heal in response to the antibiotic paste
Participants will
Undergo standard surgery to remove dead bone and drain any pus
Antibiotic paste is injected directly into the middle of the bone at surgery This is instead of receiving antibiotics directly into their bloodstream for 6 weeks
Recieve one week of tablet antibiotics
Visit clinic 1 month after surgery for a normal clinical appointment After a research team member will ask the participant a few questions The participant will also have a foot x-ray wound photograph and fill out a short questionnaire
Visit clinic 6 months and 12 months following the surgery A research team member will ask the participant a few questions The participant will also have a foot x-ray wound photograph and fill out a short questionnaire
How does the bone infection heal in response to the antibiotic paste
Participants will
Undergo standard surgery to remove dead bone and drain any pus
Antibiotic paste is injected directly into the middle of the bone at surgery This is instead of receiving antibiotics directly into their bloodstream for 6 weeks
Recieve one week of tablet antibiotics
Visit clinic 1 month after surgery for a normal clinical appointment After a research team member will ask the participant a few questions The participant will also have a foot x-ray wound photograph and fill out a short questionnaire
Visit clinic 6 months and 12 months following the surgery A research team member will ask the participant a few questions The participant will also have a foot x-ray wound photograph and fill out a short questionnaire
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