Condition category
Infections and Infestations
Date applied
19/02/2011
Date assigned
24/05/2011
Last edited
10/01/2012
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

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

  1. 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.

Additional files

Editorial Notes