ANTICS: Antibiotic implant in cardiac surgery

A randomised, controlled, patient and assessor blind pilot study of a collagen implant (GentaFleece™) for the prevention of sternal wound infection in cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57443262

Enrollment

200

Registered

2011-02-17

Start date

2010-11-29

Completion date

Unknown

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular

Interventions

GentaFleece™: antibiotic-impregnated collagen fleece inserted at closure of sternal wound following cardiac surgery. Follow-up length: 2 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older, either sex 2. Undergoing cardiac surgery through the sternum (sternotomy) 3. Provided informed consent to participate

Exclusion criteria

Exclusion criteria: 1. Patients admitted for emergency surgery 2. Pregnant or lactating females 3. Patients with a known hypersensitivity to collagen and/or gentamicin and other aminoglycoside antibiotics 4. Patients with a history of autoimmune diseases in which gentamicin is contraindicated (e.g., Parkinson's disease or myasthenia gravis) 5. Serum creatinine more than 200 µmol/l within 2 weeks pre-operatively 6. Chronic renal failure on dialysis 7. Participating in another clinical research study

Design outcomes

Primary

Measure	Time frame
ASEPSIS score, measured at day 2, day 4 and week 8 following surgery	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026