ANTICS: Antibiotic implant in cardiac surgery

ISRCTN	ISRCTN57443262
DOI	https://doi.org/10.1186/ISRCTN57443262
Secondary identifying numbers	9514

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Adrian Marchbank
Scientific

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Phone	+44 1752 431825
Email	adrian.marchbank@phnt.swest.nhs.uk

Study design	Single-centre randomised interventional pilot/feasibility study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	A randomised, controlled, patient and assessor blind pilot study of a collagen implant (GentaFleece™) for the prevention of sternal wound infection in cardiac surgery
Study acronym	ANTICS
Study objectives	The study aims to assess the role of local treatment with a collagen-gentamicin implant in the reduction of sternal wound infections in a cardiac surgical population.
Ethics approval(s)	MREC approved, ref: 10/H0206/30
Health condition(s) or problem(s) studied	Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention	GentaFleece™: antibiotic-impregnated collagen fleece inserted at closure of sternal wound following cardiac surgery. Follow-up length: 2 months
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	GentaFleece™
Primary outcome measure	ASEPSIS score, measured at day 2, day 4 and week 8 following surgery
Secondary outcome measures	Not provided at time of registration
Overall study start date	29/11/2010
Completion date	30/12/2011

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 200; UK sample size: 200
Key inclusion criteria	1. Aged 18 years or older, either sex 2. Undergoing cardiac surgery through the sternum (sternotomy) 3. Provided informed consent to participate
Key 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
Date of first enrolment	29/11/2010
Date of final enrolment	30/12/2011

Derriford Hospital

Plymouth
PL6 8DH
United Kingdom

Plymouth Hospitals NHS Trust (UK)
Hospital/treatment centre

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
England
United Kingdom

Website	http://www.plymouthhospitals.nhs.uk/Pages/Home.aspx
"ROR"	https://ror.org/05x3jck08

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

11/05/2017: No publications found in PubMed, verifying study status with principal investigator