Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2025-12-17 @ 9:06 AM
Study NCT ID:
NCT05766670
Status:
None
Last Update Posted:
2025-10-30 00:00:00
First Post:
2023-02-27 00:00:00
Brief Title:
Intramedullary Calcium Sulfate Antibiotic Depot
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Status:
None
Status Verified Date:
2025-10
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:
None
Brief Summary:
This research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture. The proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment. This is in addition to standard of care wound care, fracture fixation with intramedullary nailing, and peri-operative systemic antibiotics.
This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing.
The target population for the proposed study is patients with severe open tibia fractures (Type II or III) who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization.
One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot.
Participants will be followed for 12 months (data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).
This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing.
The target population for the proposed study is patients with severe open tibia fractures (Type II or III) who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization.
One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot.
Participants will be followed for 12 months (data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).
Detailed Description:
This research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture The proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment This is in addition to standard of care wound care fracture fixation with intramedullary nailing and peri-operative systemic antibiotics
This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing
The target population for the proposed study is patients with severe open tibia fractures Type II or III who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization
One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot
Participants will be followed for 12 months data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline 6 weeks 3 months 6 months and 12 months
This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing
The target population for the proposed study is patients with severe open tibia fractures Type II or III who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization
One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot
Participants will be followed for 12 months data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline 6 weeks 3 months 6 months and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None