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

University of Giessen

Status: Completed

Conditions: Cardiac Surgery; Wound Healing Disorder; Wound Infection

Treatments: Procedure: cardiac surgery via median sternotomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06713629

AZ 62/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

PICO arm

Experimental group

Description:

PICO vacuum system for post-sternotomy wound

Treatment:

Procedure: cardiac surgery via median sternotomy

Control arm

Active Comparator group

Description:

usual commercial wound dressing

Treatment:

Procedure: cardiac surgery via median sternotomy