Compression Device to Reduce Pocket Hematoma After Cardiac Implantable Electronic Device Implantation in a High Bleeding Risk Population

NACompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

June 1, 2024

Study Completion Date

September 1, 2024

Conditions
Pocket Hematoma
Interventions
DEVICE

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."

DEVICE

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.

Trial Locations (1)

2610

Cardiology, Wilrijk

Sponsors
All Listed Sponsors
collaborator

Merit Medical Systems, Inc.

INDUSTRY

lead

Maxime Tijskens

OTHER

NCT06748573 - Compression Device to Reduce Pocket Hematoma After Cardiac Implantable Electronic Device Implantation in a High Bleeding Risk Population | Biotech Hunter | Biotech Hunter