The Use of PlCO-Vacuum-System on Sternal Wounds

Not Applicable

Completed

• Conditions: Cardiac Surgery; Wound Infection; Wound Healing Disorder

• Registration Number: NCT06713629
• Lead Sponsor: University of Giessen

Brief Summary

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.

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 Timeline

• Study Start: 2019-07-01
• Primary Completion: 2024-02-29
• Study First Submitted: 2024-04-09
• Study Completion: 2024-05-30
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Infection at 30 POD	until day 30 post-surgery	Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively

Secondary Outcome Measures

Name	Time	Method
Infection at 180 Postoperative Days (POD)	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.
Patient satisfaction	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

Trial Locations

Locations (2)

Cardiac Surgery, Kerckhoff Heart Center; 🇩🇪 Bad Nauheim, Hessen, Germany

Cardiovascular Surgery, University Hospital Giessen; 🇩🇪 Giessen, Hessen, Germany