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Completed

NCT Number: NCT06713629

The Use of PlCO-Vacuum-System on Sternal Wounds

The use of a vacuum-assisted wound closure system (PICO, Fa. Smith & Nephew) is being investigated to determine whether it reduces the incidence of sternal wound healing disorders compared to conventional wound care with plaster.

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Key information

Conditions

Cardiac Surgery Infections Wound Healing Disorder Wound Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Hesse, Germany

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About this study

Median sternotomy remains the standard surgical approach for most cardiac surgeries. However, postoperative wound infections can occur and may progress to mediastinitis, a life-threatening complication with significant mortality. This risk is particularly pronounced in cases where sternal perfusion is compromised, such as when one or both internal mammary arteries are harvested during coronary artery bypass grafting. In such scenarios, the incidence of sternal wound healing disturbances is estimated to range from 2% to 7%.

Several strategies aim to reduce the risk of sternal wound infections. One approach involves external stabilization using a thoracic vest, which has been shown to significantly decrease sternal instability and healing disorders when implemented early in the postoperative period. Another approach utilizes negative pressure wound therapy, which has demonstrated efficacy in reducing sternal wound healing complications in prior studies involving systems like Prevena (Fa. KCI).

The PICO-System operates with a distinct vacuum pressure mechanism and a unique film design compared to the Prevena system. To date, no prospective randomized studies have evaluated the PICO-System for its effectiveness in reducing sternal healing disturbances, sternal instability, and mediastinitis. This study aims to compare conventional plaster wound care with the PICO vacuum system in a randomized, prospective design, assessing outcomes up to six months postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients undergoing cardiac surgery by means of median sternotomy and exhibiting more than one of the following risk factors:

  • Diabetes mellitus (treated with oral antidiabetics and/or insulin)
  • LVEF<40%
  • COPD
  • Female gender
  • Adipositas (BMI > 30kg/m2)
  • History of myocardial infarction (NSTEMI or STEMI) within 14 days
  • Known peripheral arterial disease
  • Planned BIMA surgery.

Exclusion criteria

  • Planned hemisternotomy or anterolateral thoracotomy
  • Emergency cases
  • Lack of consent
  • Active therapy with immunosuppressants (including steroids)

Treatment and study plan

cardiac surgery via median sternotomy

Procedure

For both groups, the same median sternotomy cardiac surgery procedure

Other names: wound dressing, PlCO-Vacuum dressing

Primary outcomes

  1. Infection at 30 POD

    Time frame: until day 30 post-surgery

    Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively

Secondary outcomes

  1. Infection at 180 Postoperative Days (POD)

    Time frame: Up to 180 days post-surgery

    Rates of superficial and/or deep sternal wound healing disorders assessed using standardized clinical criteria, including infection signs (e.g., erythema, purulent discharge), radiological imaging (if indicated), microbiological culture results, and adherence to validated classification systems such as the CDC's surgical site infection (SSI) criteria.

  2. Patient satisfaction

    Time frame: until day 7 post-surgery

    Patient satisfaction with the PICO-System in comparison to conventional plasters:

    The following questions were assessed to evaluate participant satisfaction:

    • The wound dressing causes discomfort.
    • My wound has achieved a satisfactory cosmetic appearance.
    • I experienced pain during wound dressing changes.
    • I am generally satisfied with the care provided.

    For each question, the following response options were offered:

    • Fully applies
    • Partially applies
    • Neutral
    • Partially does not apply
    • Does not apply

Other outcomes

  1. Cost-Effectiveness of PICO Wound Dressing Compared to Conventional Plaster Dressing

    Time frame: From surgery to day 180 post-surgery

    The cost-effectiveness analysis will assess the direct and indirect costs associated with the use of PICO vacuum-assisted wound dressings compared to conventional plaster dressings in patients undergoing median sternotomy. Costs will include initial purchase price, frequency of dressing changes, associated resource utilization (e.g., hospital readmissions, additional interventions for wound healing disorders), and postoperative complications such as sternal instability, wound infections, and mediastinitis. Data will be aggregated and reported using descriptive statistics, incremental cost-effectiveness ratios.

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Kerckhoff Heart Center
  • Smith & Nephew, Inc.

Registry information

Acronym: PICO sternal

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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