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GENTAmicin-collagen sponge reduces sternal wound complications after heart surgery

GENTAmicin-collagen sponge reduces sternal wound complications after heart surgery: a prospective, double-blind, randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27652441
Enrollment
800
Registered
2011-05-24
Start date
2011-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sternal wound infection Infections and Infestations Sternal wound infection

Interventions

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 stern

Sponsors

University Hospital of Würzburg (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Mediastinitis-occurrence of deep sternal wound (DSWI) infections within 30 days of index surgery (follow-up period)

Secondary

MeasureTime frame
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.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026