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Antibiotic Therapy is Not Necessary to Implant Totally Implantable Venous Access Devices: Randomized Prospective Study

NCT00665873 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-05-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

PORT-A-CATH (Smiths Medical Inc., MN)

Port a Cath implanted by surgical cut-down

DRUG

Amoxicillin and clavulanic acid

1 gr i.v. before the procedure

Sponsors & Collaborators

  • Universita degli Studi di Catania

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2006-09-30
Completion
2006-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665873 on ClinicalTrials.gov