Penetration of Ertapenem Into Bone
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, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Haemek Medical Center INFECTIOUS DISEASES UNIT
HaEmek Medical Center, Israel
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00392028
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
The part of a limb or tail following amputation that is proximal to the amputated section.
Amputation or separation at a joint. (Dorland, 28th ed)
Amputation of a lower limb through the sacroiliac joint.
The removal of a limb or other appendage or outgrowth of the body. (Dorland, 28th ed)
Loss of a limb or other bodily appendage by accidental injury.
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