Does Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?

NCT ID: NCT06508879

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-08-31

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.

Conditions

Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Standard Care (sterile gauze and adhesive tape)

Intervention Type: OTHER

Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms.

Test Group

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.

Group Type: EXPERIMENTAL

Aquacel Ag Surgical®

Intervention Type: COMBINATION_PRODUCT

Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms.

Interventions

Aquacel Ag Surgical®

Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms.

Intervention Type: COMBINATION_PRODUCT

Standard 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

University Medical Center Mainz

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Kathrin Dohle

Cardiac surgery specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiovascular Surgery, University Hospital of Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

Other Identifiers

OHSCWD for sternotomy

Identifier Type: -

Identifier Source: org_study_id