Clinical trial NCT06713629: The Use of PlCO-Vacuum-System on Sternal Wounds
Official title: The Use of PlCO-Vacuum-System on Sternal Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Wound Infection
Wound Healing Disorder
Keywords: vacuum wound dressing
PICO
sternal wound healing disorder
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
name: Kerckhoff Heart Center
First posted: 2024-12-03
Enrollment: 256
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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\&lt;40%
* COPD
* Female gender
* Adipositas (BMI \&gt; 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)

Primary outcomes:
measure: Infection at 30 POD
timeFrame: until day 30 post-surgery
Secondary outcomes:
measure: Infection at 180 Postoperative Days (POD)
timeFrame: Up to 180 days post-surgery
measure: Patient satisfaction
timeFrame: until day 7 post-surgery
Other outcomes:
measure: Cost-Effectiveness of PICO Wound Dressing Compared to Conventional Plaster Dressing
timeFrame: From surgery to day 180 post-surgery
Locations:
city: Bad Nauheim
country: Germany
facility: Cardiac Surgery, Kerckhoff Heart Center
state: Hessen
city: Giessen
country: Germany
facility: Cardiovascular Surgery, University Hospital Giessen
state: Hessen
Study officials:
References: