GENTAmicin-collagen sponge reduces sternal wound complications after heart surgery

ISRCTN	ISRCTN27652441
DOI	https://doi.org/10.1186/ISRCTN27652441
Secondary identifying numbers	N/A

Submission date: 19/02/2011
Registration date: 24/05/2011
Last edited: 10/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rainer Leyh
Scientific

University Hospital of Würzburg
Department for Thoracic, Cardiac and Thoracic Vascular Surgery
Oberdürrbacherstraße 6
Wuerzburg
97074
Germany

Email	Leyh_r@klinik.uni-wuerzburg.de

Study information

Study design	Prospective double-blind randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	GENTAmicin-collagen sponge reduces sternal wound complications after heart surgery: a prospective, double-blind, randomised controlled study
Study acronym	GENTA
Study objectives	Gentamicin-collagen sponge reduces sternal wound complications after heart surgery.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Gentamicin-collagen sponge
Primary outcome measure	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 study start date	01/03/2011
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	800
Key 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
Key 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
Date of first enrolment	01/03/2011
Date of final enrolment	01/04/2011

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital of Würzburg

Wuerzburg
97074
Germany

Sponsor information

University Hospital of Würzburg (Germany)
Hospital/treatment centre

Department for Thoracic, Cardiac and Thoracic Vascular Surgery
c/o Dr. Schimmer
Oberdürrbacherstraße 6
Wuerzburg
97074
Germany

Email	Schimmer_c@klinik.uni-wuerzburg.de
"ROR"	https://ror.org/03pvr2g57

Funders

Funder type

Industry

Resorba Wound Care (Wundversorgung) GmbH & Co. KG (Germany)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No