Condition category
Injury, Occupational Diseases, Poisoning
Date applied
17/02/2011
Date assigned
17/02/2011
Last edited
02/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Adrian Marchbank

ORCID ID

Contact details

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
adrian.marchbank@phnt.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9514

Study information

Scientific title

Acronym

ANTICS: ANTibiotic Implant in Cardiac Surgery

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 measures

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

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

http://www.plymouthhospitals.nhs.uk/Pages/Home.aspx

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes