Contact information
Type
Scientific
Primary contact
Mr Adrian Marchbank
ORCID ID
Contact details
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
+44 1752 431825
adrian.marchbank@phnt.swest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9514
Study information
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
Acronym
ANTICS
Study hypothesis
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
MREC approved, ref: 10/H0206/30
Study design
Single-centre randomised interventional pilot/feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
29/11/2010
Overall trial end date
30/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older, either sex
2. Undergoing cardiac surgery through the sternum (sternotomy)
3. Provided informed consent to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 200; UK sample size: 200
Participant 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
Recruitment start date
29/11/2010
Recruitment end date
30/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Plymouth Hospitals NHS Trust (UK)
Sponsor details
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list