Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Universita degli Studi di Catania
ClinicalTrials.gov Identifier:
NCT00665873
First received: April 2, 2008
Last updated: May 7, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Infections
Device: PORT-A-CATH (Smiths Medical Inc., MN)
Drug: Amoxicillin and clavulanic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Antibiotic Therapy is Not Necessary to Implant Totally Implantable Venous Access Devices: Randomized Prospective Study

Resource links provided by NLM:


Further study details as provided by Universita degli Studi di Catania:

Enrollment: 100
Study Start Date: January 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Antibiotics
Device: PORT-A-CATH (Smiths Medical Inc., MN)
Port a Cath implanted by surgical cut-down
Other Name: Totally implantable venous access device (TIVAD)
Drug: Amoxicillin and clavulanic acid
1 gr i.v. before the procedure
Other Name: Antibiotics vs no antibiotics
Active Comparator: B
No Antibiotics
Device: PORT-A-CATH (Smiths Medical Inc., MN)
Port a Cath implanted by surgical cut-down
Other Name: Totally implantable venous access device (TIVAD)

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Isidoro DI CARLO, MD, PhD, FACS, University of Catania
ClinicalTrials.gov Identifier: NCT00665873     History of Changes
Other Study ID Numbers: 1-28064152
Study First Received: April 2, 2008
Last Updated: May 7, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by Universita degli Studi di Catania:
Totally Implantable Venous Access Devices
Infections
Chemotherapy
Valuated infections TIVAD

Additional relevant MeSH terms:
Communicable Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014