Contact information
Type
Scientific
Primary contact
Prof Rainer Leyh
ORCID ID
Contact details
University Hospital of Würzburg
Department for Thoracic
Cardiac and Thoracic Vascular Surgery
Oberdürrbacherstraße 6
Wuerzburg
97074
Germany
Leyh_r@klinik.uni-wuerzburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
GENTAmicin-collagen sponge reduces sternal wound complications after heart surgery: a prospective, double-blind, randomised controlled study
Acronym
GENTA
Study hypothesis
Gentamicin-collagen sponge reduces sternal wound complications after heart surgery.
Ethics approval
Not provided at time of registration
Study design
Prospective double-blind randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sternal wound infection
Intervention
From June 2009 to June 2010, 723 out of 994 patients (72.7%) were enrolled (control group: n=369 versus intervention group: n=354). 723 consecutive cardiac surgery patients who underwent median sternotomy were assigned either to a control placebo-group (collagen sponge) or an intervention-group (gentamicin-collagen sponge). All patients received intevenous (i.v.) perioperative antibiotic prophylaxis.
All operations were performed on the heart and thoracic aorta via median sternotomy at the Clinic for Thoracic, Cardiac and Thoracic Vascular Surgery of Würzburg University Hospital.
Intervention type
Drug
Phase
Not Applicable
Drug names
Gentamicin-collagen sponge
Primary outcome measures
Mediastinitis-occurrence of deep sternal wound (DSWI) infections within 30 days of index surgery (follow-up period)
Secondary outcome measures
Occurrence of superficial wound infections (SSWI) requiring treatment, as well as further clinical parameters, including revision, bleeding volume, and need for transfusions during the follow-up period.
Overall trial start date
01/03/2011
Overall trial end date
01/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female legally competent patient, aged 18 years or older
2. Cardiac surgery undergoing median sternotomy
3. Ability to provide written informed consent
4. No preoperative signs of thoracic inflammation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant exclusion criteria
1. Existing osteitis, immunosuppressive therapy, known hypersensitivity to aminoglycoside antibiotics
2. Concurrent immunological disease
3. Pregnancy or lactation
4. Participation in another clinical study
5. Inability to give consent to participate in the study
6. Refusal to participate in the study before and/or during the follow-up period
Recruitment start date
01/03/2011
Recruitment end date
01/04/2011
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital of Würzburg
Wuerzburg
97074
Germany
Sponsor information
Organisation
University Hospital of Würzburg (Germany)
Sponsor details
Department for Thoracic
Cardiac and Thoracic Vascular Surgery
c/o Dr. Schimmer
Oberdürrbacherstraße 6
Wuerzburg
97074
Germany
Schimmer_c@klinik.uni-wuerzburg.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Resorba Wound Care (Wundversorgung) GmbH & Co. KG (Germany)
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21885068
Publication citations
-
Results
Schimmer C, Özkur M, Sinha B, Hain J, Gorski A, Hager B, Leyh R, Gentamicin-collagen sponge reduces sternal wound complications after heart surgery: a controlled, prospectively randomized, double-blind study., J. Thorac. Cardiovasc. Surg., 2012, 143, 1, 194-200, doi: 10.1016/j.jtcvs.2011.05.035.