GENTAmicin-collagen sponge reduces sternal wound complications after heart surgery
| ISRCTN | ISRCTN27652441 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27652441 |
| Protocol serial number | N/A |
| Sponsor | University Hospital of Würzburg (Germany) |
| Funder | Resorba Wound Care (Wundversorgung) GmbH & Co. KG (Germany) |
- 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
Scientific
University Hospital of Würzburg
Department for Thoracic, Cardiac and Thoracic Vascular Surgery
Oberdürrbacherstraße 6
Wuerzburg
97074
Germany
| Leyh_r@klinik.uni-wuerzburg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective double-blind randomised controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gentamicin-collagen sponge |
| Primary outcome measure(s) | Mediastinitis-occurrence of deep sternal wound (DSWI) infections within 30 days of index surgery (follow-up period) |
| Key secondary outcome measure(s) | 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. |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
97074
Germany
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? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
