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

Phase 4
18 Years
Not Enrolling

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Trial Information

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

PATIENTS AND METHODS One hundred consecutive patients were enrolled for the present study
from January 2004 to September 2006. The patients were divided into two arms, each of 50
patients, and they were randomized using sealed envelopes that were opened only in the
operating room 30 min before the start of the procedure. All the patients were aged more
than 18 years and were affected by solid tumors. In all the patients, the TIVAD was
necessary to infuse chemotherapy continuously. The type of device utilized in all patients
was composed of a catheter of polyurethane and a titanium portal reservoir covered with
polysulfone (PORT-A-CATH, Smiths Medical Inc., MN).

Age, gender, comorbidity (cardiovascular, pulmonary, renal, hepatic, coagulopathy,
diabetes), white cells, platelets, prothrombin time (less than 70%), kind of tumoral
disease, numbers of chemotherapeutical cures before the surgical procedure, experience of
surgeons (resident or surgeon), preparation of the skin of the patients, time and kind of
hand scrub of the surgeons, kind of antibiotic used, and time of administration were
considered for the present study. All the devices were implanted in the operating room using
the cephalic vein dissected surgically; the technique used has been previously described.3
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. Eight days after the surgical procedure, sutures of the skin were removed. The
skin wound was covered with a sterile drape until the ninth postoperative day. After this
time, the patients used any skin protection, but the skin wound was checked one time each
week for a total of 30 days. All the devices were used to infuse chemotherapy drugs 10 days
after the surgical procedure. From the 10th to the 30th days, the devices were used, at
minimum, one time.

A single dose of cephalosporin (1 gr of amoxicillin and clavulanic acid ) was administered
intravenously 10 min before the skin incision.

For the surgical site infections (SSI), the criteria of the Centers for Disease Control and
Prevention (CDC), Atlanta, Georgia,9 were applied. By these criteria, SSIs are classified as
being either incisional or organ/space. Incisional SSIs are further divided into those
involving only skin and subcutaneous tissue (superficial incisional SSI) and those involving
deeper soft tissues of the incision (deep incisional SSI). Organ/space SSIs involve any part
of the anatomy (e.g., organ or space) other than incised body wall layers that was opened or
manipulated during the operation (Fig. 1).

The following signs or symptoms for defining a superficial incisional infection were
considered: pain, localized swelling, redness, and heat.9 Infection was considered if these
signs and symptoms occurred within 30 days after the surgical procedure, and the end points
were considered to be a body temperature more than 37.5°C, white cells more than 11,000
K/æL, and one or more of the following signs: pain, localized swelling, redness, or heat.

The state of the skin was evaluated in people with the same surgical team, which was
composed of the surgeons (one skilled, with more than 400 previous procedures, and one
resident, with 20 previous procedures) and two nurses.

Following these rules, depending on the results of a computer-generated randomization
enclosed in sealed envelopes, 100 patients were divided into two groups of 50 patients:
group A (patients were submitted to the short-term prophylaxis with cefalosporin 10 min
before skin incision) and group B (patients without any antibiotic prophylaxis). All the
patients were hospitalized the night after the surgical procedure. A statistical study, to
compare the means and standard deviations of each group, was performed using Student's
t-test (independent, two-sided).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Italy: Ministry of Health

Study ID:




Start Date:

January 2004

Completion Date:

September 2006

Related Keywords:

  • Infections
  • Totally Implantable Venous Access Devices
  • Infections
  • Chemotherapy
  • Valuated infections TIVAD