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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | a standard wound dressing composed of sterile gauze and adhesive tape was applied under sterile conditions. In the absence of bleeding, excessive wound secretion, or detachment, the dressing was left on the wound until the second postoperative day (POD 2), otherwise, it was changed immediately. Starting at POD 2, the dressing was changed daily under aseptic conditions until the wound remained dry (between POD 3-5). In the absence of bleeding, excessive wound secretion, or detachment, the wound was then left uncovered. This practice corresponded to the standard treatment of cardiothoracic patients in our department at the time of initiating this study. |
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| Test Group | Experimental | directly after closing the wound, an occlusive hydrocolloid silver-containing wound dressing (Aquacel Ag Surgical®, ConvaTec, Oklahoma City, OK, USA) was applied under sterile conditions and, in the absence of bleeding; excessive wound secretion, or detachment, was maintained on the wound until POD 5, at which time the dressing was removed. In case of bleeding, excessive wound secretion, or detachment, the dressing was removed, the wound was cleaned, and a new sterile hydrocolloid wound dressing applied under aseptic conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquacel Ag Surgical® | Combination Product | Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms. |
| Measure | Description | Time Frame |
|---|---|---|
| SSI rate | overall rate of incidence of any kind of SSI | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| dressing changes | 7 days | |
| severity of SSI | 30 days | |
| need for treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Surgery, University Hospital of Johannes Gutenberg University Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
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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.
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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.
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| Standard Care (sterile gauze and adhesive tape) | Other | Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms. |
|
| 30 days |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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