The Use of PlCO-Vacuum-System on Sternal Wounds (PICO sternal)

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Wound Infection; Wound Healing Disorder
• Intervention / Treatment: Procedure: cardiac surgery via median sternotomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
      • Cardiac Surgery, Kerckhoff Heart Center
    • Giessen, Hessen, Germany, 35392
      • Cardiovascular Surgery, University Hospital Giessen

Participation Criteria

Eligibility Criteria

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

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICO arm; PICO vacuum system for post-sternotomy wound	Procedure: cardiac surgery via median sternotomy; For both groups, the same median sternotomy cardiac surgery procedure; Other Names: wound dressing; PlCO-Vacuum dressing
Active Comparator: Control arm; usual commercial wound dressing	Procedure: cardiac surgery via median sternotomy; For both groups, the same median sternotomy cardiac surgery procedure; Other Names: wound dressing; PlCO-Vacuum dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection at 30 POD	Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively	until day 30 post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection at 180 Postoperative Days (POD)	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.	Up to 180 days post-surgery
Patient satisfaction	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	until day 7 post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-Effectiveness of PICO Wound Dressing Compared to Conventional Plaster Dressing	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.	From surgery to day 180 post-surgery

Collaborators and Investigators

• Sponsor: University of Giessen
• Collaborators: Smith & Nephew, Inc.; Kerckhoff Heart Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: PICO; vacuum wound dressing; sternal wound healing disorder
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: AZ 62/19

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