Status:
COMPLETED
Does Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?
Lead Sponsor:
University Medical Center Mainz
Collaborating Sponsors:
German Research Foundation
Conditions:
Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Wound healing disorders are a major problem in cardiac surgery. They prolong the inpatient stay and are associated with a high health and, above all, psychological burden for patients. They also repre...
Eligibility Criteria
Inclusion
- Coronary artery bypass surgery
- Elective and primary surgery (no reoperations)
- Complete median sternotomy
- Age under 90 years
- Weight in the range of 50-140kg
- No known allergy to silver or other wound dressings
- No immunosuppressive therapy or hormonal substitution therapy, except for thyroid hormone
- Capacity to consent
Exclusion
- Failure of medical personnel to adhere to study protocol, e.g., not applying the right wound dressing according to study protocol
- Patients own decision
- Lack of harvesting of at least one internal thoracic artery
- Peri- and post-operative ventilation for \>48h
- Re-thoracotomy for reasons other than SSI, e.g., bleeding
- Mortality within the first 30 days
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT06508879
Start Date
January 1 2018
End Date
August 31 2019
Last Update
July 18 2024
Active Locations (1)
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1
Department of Cardiovascular Surgery, University Hospital of Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany, 55131