ANTICS: Antibiotic implant in cardiac surgery
| ISRCTN | ISRCTN57443262 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57443262 |
| Protocol serial number | 9514 |
| Sponsor | Plymouth Hospitals NHS Trust (UK) |
| Funder | National Institute for Health Research |
- Submission date
- 17/02/2011
- Registration date
- 17/02/2011
- Last edited
- 11/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Contact information
Mr Adrian Marchbank
Scientific
Scientific
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
| Phone | +44 1752 431825 |
|---|---|
| adrian.marchbank@phnt.swest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional pilot/feasibility study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | GentaFleece™ |
| Primary outcome measure(s) |
ASEPSIS score, measured at day 2, day 4 and week 8 following surgery |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/05/2017: No publications found in PubMed, verifying study status with principal investigator
