65
Participants
Start Date
June 1, 2023
Primary Completion Date
June 1, 2024
Study Completion Date
September 1, 2024
SafeGuard FocusTM compression bandage
"If randomized to the study group, The study device was applied immediately after pocket closure using following steps:~* Preparation: cleaning wound and surrounding area.~* Placement: application of isobetadine gauze and transparent bandage. Study device placement at the level of the pocket.~* Applying compression: inflation of 60ml of air. If oozing persisted 5ml increments were added (maximum of 120ml) until oozing stopped.~The study device was gradually deflated by removal of 20ml of air every 2 hours. When oozing occurred 5ml increments were added until oozing stopped. When all air was deflated the study device was left in deflated mode and changed by conventional bandage at discharge."
Conventional bandage
If randomized to the control group, compressive bandage was applied immediately after pocket closure. The bandage was removed after 6 hours and changed by conventional bandage.
Cardiology, Wilrijk
Collaborators (1)
Merit Medical Systems, Inc.
INDUSTRY
Maxime Tijskens
OTHER