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

NCT00665873 | Completed Phase 4 DMC

• 1 other identifier: 1-28064152
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Infections

Keywords

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

Study Arms (2)

A

ACTIVE COMPARATOR

Antibiotics

Device: PORT-A-CATH (Smiths Medical Inc., MN); Drug: Amoxicillin and clavulanic acid

B

ACTIVE COMPARATOR

No Antibiotics

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

Interventions

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

Port a Cath implanted by surgical cut-down

Also known as: Totally implantable venous access device (TIVAD)

A; B

Amoxicillin and clavulanic acid DRUG

1 gr i.v. before the procedure

Also known as: Antibiotics vs no antibiotics

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Universita degli Studi di Catania: lead

MeSH Terms

Conditions

Infections

Interventions

Vascular Access Devices; Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 24, 2008
• Study Start: January 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: May 8, 2008

Record last verified: 2008-05