Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392028
Status:
WITHDRAWN
Last Update Posted:
2007-07-13
First Post:
2006-10-24
Brief Title:
Penetration of Ertapenem Into Bone
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
Official Title:
Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation
Status:
WITHDRAWN
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus DM or Peripheral Vascular Diseases PVD undergoing amputation and to correlate theme to the concentration of the drug in blood and other soft tissues
Detailed Description:
Twelve patients with DM or PVD who are undergoing bellow knee amputation with or without gangrene
Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements TcPO2 on the dorsal side of the mid foot of the affected limb
Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC
-2 days prior the amputation
-1 day prior the amputation
1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion prior the planned amputation
Blood samples approximately 6ml each will be collected before Ertapenem administration simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery
Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements TcPO2 on the dorsal side of the mid foot of the affected limb
Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC
-2 days prior the amputation
-1 day prior the amputation
1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion prior the planned amputation
Blood samples approximately 6ml each will be collected before Ertapenem administration simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery
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