Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care
Conditions
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 represent a major organizational, medical and financial challenge for the treatment team. There is therefore still a great need for effective prevention of wound healing disorders. It goes without saying that wound management plays a major role in the development of wound healing disorders. Nowadays, there are a large number of products from various manufacturers and studies for efficient wound healing disorder prophylaxis. One point of criticism is that most of the existing studies are financed by the manufacturer. Due to the otherwise broad range of applications for all wounds in various specialist areas, it remains to be clarified whether such products can achieve a reduction in the rate of wound healing disorders, especially in cardiac surgery. After extensive literature research, we are of the opinion that the Aquacel Surgical Ag dressing, a new silver-coated hydrocolloid dressing, can be offered to cardiac surgery patients at our clinic as an effective prophylaxis against wound healing disorders.The study is a randomized prospective clinical trial. It is being conducted at the Clinic for Cardiothoracic and Vascular Surgery and has already been approved by the Rhineland-Palatinate Ethics Committee. The study should include 440 heart patients and last for 12 months. It will compare the Aquacel Surgical Ag bandage against our conventional methods. This study is being conducted independently of the industry. We want to prove that an intelligent investment in the prophylaxis of wound healing disorders is worthwhile for both patients and the clinic. If the outcome of the study is positive, this dressing will be be used regularly in our cardiac surgery clinic.
Interventions
COMBINATION_PRODUCTAquacel Ag Surgical®
Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms.
OTHERStandard Care (sterile gauze and adhesive tape)
Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms.
Sponsors
German Research Foundation
University Medical Center Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
The patients were blinded until the time of the intervention (application of the bandage after surgery). Due to the nature of this study, it was not possible to conceal the treatment after the procedure, as patients could see their bandages and find out their allocation. Using methods to conceal the dressings (covering with neutral dressing) would have changed the nature of the dressings and affected the treatment. The study team could also see the bandages and was therefore not blinded.
Intervention model description
This study was designed as a single-center randomized controlled trial. Primary endpoint was overall rate of incidence of any kind of SSI. Secondary endpoints were number of dressing changes, severity of SSI and need for treatment. Wounds were monitored daily until the 7th and on the 30th postoperative day.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Coronary artery bypass surgery 2. Elective and primary surgery (no reoperations) 3. Complete median sternotomy 4. Age under 90 years 5. Weight in the range of 50-140kg 6. No known allergy to silver or other wound dressings 7. No immunosuppressive therapy or hormonal substitution therapy, except for thyroid hormone 8. Capacity to consent
Exclusion criteria
1. Failure of medical personnel to adhere to study protocol, e.g., not applying the right wound dressing according to study protocol 2. Patients own decision 3. Lack of harvesting of at least one internal thoracic artery 4. Peri- and post-operative ventilation for \>48h 5. Re-thoracotomy for reasons other than SSI, e.g., bleeding 6. Mortality within the first 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSI rate | 30 days | overall rate of incidence of any kind of SSI |
Secondary
| Measure | Time frame |
|---|---|
| dressing changes | 7 days |
| severity of SSI | 30 days |
| need for treatment | 30 days |
Countries
Germany
Outcome results
None listed