Antibiotic Therapy is Not Necessary to Implant Totally Implantable Venous Access Devices: Randomized Prospective Study
NCT ID: NCT00665873
Last Updated: 2008-05-08
Study Results
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Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2004-01-31
2006-09-30
Brief Summary
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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.
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Antibiotics
PORT-A-CATH (Smiths Medical Inc., MN)
Port a Cath implanted by surgical cut-down
Amoxicillin and clavulanic acid
1 gr i.v. before the procedure
B
No Antibiotics
PORT-A-CATH (Smiths Medical Inc., MN)
Port a Cath implanted by surgical cut-down
Interventions
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PORT-A-CATH (Smiths Medical Inc., MN)
Port a Cath implanted by surgical cut-down
Amoxicillin and clavulanic acid
1 gr i.v. before the procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Universita degli Studi di Catania
OTHER
Responsible Party
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University of Catania
Other Identifiers
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1-28064152
Identifier Type: -
Identifier Source: org_study_id