Clinical trial NCT06508879: Does Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?
Official title: Randomized Controlled Trial: Does the Use of Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care
Lead sponsor: University Medical Center Mainz
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2024-07-18
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: SSI rate
timeFrame: 30 days
Secondary outcomes:
measure: dressing changes
timeFrame: 7 days
measure: severity of SSI
timeFrame: 30 days
measure: need for treatment
timeFrame: 30 days
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Cardiovascular Surgery, University Hospital of Johannes Gutenberg University Mainz
state: Rheinland-Pfalz
Study officials:
References: