GENTAmicin-collagen sponge reduces sternal wound complications after heart surgery
Completed
- Conditions
- Sternal wound infectionInfections and Infestations
- Registration Number
- ISRCTN27652441
- Lead Sponsor
- niversity Hospital of Würzburg (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 800
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mediastinitis-occurrence of deep sternal wound (DSWI) infections within 30 days of index surgery (follow-up period)
- Secondary Outcome Measures
Name Time Method 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.