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

Randomized Controlled Trial: Does the Use of Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care
• Intervention / Treatment: Other: Standard Care (sterile gauze and adhesive tape); Combination product: Aquacel Ag Surgical®

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Department of Cardiovascular Surgery, University Hospital of Johannes Gutenberg University Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	Combination product: Aquacel Ag Surgical®; Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSI rate	overall rate of incidence of any kind of SSI	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
dressing changes	7 days
severity of SSI	30 days
need for treatment	30 days

Collaborators and Investigators

• Sponsor: University Medical Center Mainz
• Collaborators: German Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: OHSCWD for sternotomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No