Antibiotic Therapy is Not Necessary to Implant Totally Implantable Venous Access Devices: Randomized Prospective Study
Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
Summary
BACKGROUND: The growing use of totally implantable venous access devices (TIVAD) has caused
the simultaneous increase of various complications. The infection of the TIVAD or the
subcutaneous pocket in which the device is positioned is one of the most encountered
complications. The aim of this study is to evaluate the role of the antibiotic in the
prevention of the infection of the surgical site and the TIVAD until 30 days after the
implant.
METHODS: The authors enrolled one hundred consecutive patients divided into two randomized
arms: group A (antibiotic), group B (no antibiotic), each of 50 patients. All the patients
were affected by solid tumors needing chemotherapy continuously. TIVADs were implanted
surgically in cephalic vein. Signs or symptoms considered were: pain, localized swelling,
redness, and heat. White cell count was considered on the first, third, and seventh
postoperative days, and the tests were made in the in-hospital laboratory. Body temperatures
were checked twice daily for 7 days.