Amputation Clinical Trial
Official title:
Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation
The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues
Twelve patients with D.M or P.V.D 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
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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