NCT06713629

The Use of PlCO-Vacuum-System on Sternal Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery
• Wound Infection
• Wound Healing Disorder

Interventions

Type	Name	Description
PROCEDURE	cardiac surgery via median sternotomy	For both groups, the same median sternotomy cardiac surgery procedure

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-02-29
• Completion: 2024-05-30
• First posted: 2024-12-03
• Last updated: 2024-12-03

Locations

2 sites across 1 country: Germany