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

Summary

Your doctor has determined that you have an indication for cardiac implantation implantable electronic device (CIED = collective name for pacemaker or defibrillator). Pocket bleeding is a possible complication that occurs in 0.2-16% of cases depending on the definition used. They are an important risk factor for CIED infections (factor 9x). Other possible consequences include prolonged hospitalization risk of stroke due to discontinuation of blood thinners and even death. The main known risk factors for pocket bleeding are advanced age, heart failure, kidney failure, congenital bleeding tendency and the use of blood thinners. Have several measures to reduce the risk of pocket bleeding varying or limited effects shown in the past. Currently the standard treatment consists of applying a conventional pressure bandage at the pocket.However, the lack of targeted compression and lack of standardization has caused this only a limited effect and contributes to patient discomfort. Moreover, let a Conventional pressure dressing does not allow the pocket to be evaluated. The SafeGuard FocusTM compression bandage is a promising new option with several technical features advantages: it can deliver 2x as much pressure as a conventional pressure bandage, the amount pressure can be adjusted according to effect and patient comfort and there is a transparent window so that the surgical wound can always be inspected. This new pressure bandages already used in several countries, but has never been compared until now with a conventional pressure bandage.

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.

Sponsors & Collaborators

• Merit Medical Systems, Inc.

  collaborator INDUSTRY

• Maxime Tijskens

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2024-06-01

Completion

2024-09-01

Countries

• Belgium

Study Locations