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

NCT06508879 | Completed

• 1 other identifier: OHSCWD for sternotomy
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• SSI rate

  overall rate of incidence of any kind of SSI

  30 days

Secondary Outcomes (3)

• dressing changes

  7 days

• severity of SSI

  30 days

• need for treatment

  30 days

Study Arms (2)

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.

Other: Standard Care (sterile gauze and adhesive tape)

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.

Combination Product: Aquacel Ag Surgical®

Interventions

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.

Test Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary artery bypass surgery
• Elective and primary surgery (no reoperations)
• Complete median sternotomy
• Age under 90 years
• Weight in the range of 50-140kg
• No known allergy to silver or other wound dressings
• No immunosuppressive therapy or hormonal substitution therapy, except for thyroid hormone
• Capacity to consent

You may not qualify if:

• Failure of medical personnel to adhere to study protocol, e.g., not applying the right wound dressing according to study protocol
• Patients own decision
• Lack of harvesting of at least one internal thoracic artery
• Peri- and post-operative ventilation for \>48h
• Re-thoracotomy for reasons other than SSI, e.g., bleeding
• Mortality within the first 30 days

Sponsors & Collaborators

• University Medical Center Mainz: lead
• German Research Foundation: collaborator

Study Sites (1)

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

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac surgery specialist

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: January 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)