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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universita degli Studi di Catania
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• Age

• Gender

• Comorbidity

• White cells

• Platelets

• Prothrombin time

• Any kind of tumoral disease

• Numbers of chemotherapeutical cures before the surgical procedure

• Experience of surgeons

• Preparation of the skin of the patients

• Time and kind of hand scrub of the surgeons

• Kind of antibiotic used, and time of administration.

Exclusion Criteria:

• None