Clinical trial NCT06748573: Compression Device to Reduce Pocket Hematoma After Cardiac Implantable Electronic Device Implantation in a High Bleeding Risk Population
Official title: A Prospective Study of a Novel Pocket Compression Device to Reduce Pocket Hematoma After Cardiac Implantable Electronic Device Implantation in a High Bleeding Risk Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pocket Hematoma
Keywords: pocket hematoma
compression device
cardiac implantable electronic device
Lead sponsor: Ziekenhuis aan de Stroom
Sponsor class: OTHER
Collaborators: name: Merit Medical Systems, Inc.
First posted: 2024-12-27
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is single-center, observational, case-controlled, randomized and prospective trail conducted at the ZAS heart center. Before CIED implantation, patients were randomly assigned in a 1:1 ratio to the study group (SafeGuard FocusTM compression device) or control group (standard care with compressive bandage) using a sealed envelope system.

Inclusion criteria were all patients above 18 years of age undergoing primo CIED implantation (pacemaker, internal cardiac defibrillator or cardiac resynchronization therapy) with a high bleeding risk (as defined by at least 1 of the following risk factors: age \> 75 years, heart failure, kidney failure, antithrombotic use (double antiaggregant therapy or anticoagulation). Exclusion criteria were refusal to participate or mental illness.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Prospective study on the potential benefit of SafeGuard FocusTM compression dressing in preventing pocket bleeding after implantation of a cardiac implantable electrical device in patients with an increased risk of bleeding Introduction You are invited to participate in a research study involving up to 200 patients . The study aims to confirm the effectiveness and safety of the SafeGuard FocusTM compression bandage when compared to the conventional compression bandage. Your participation in the study will last a total of 1 month and will take place during the standard follow-up moments on the day of implantation, the next day and the first check-up after 1 month. So no additional follow-up moments are required. Before you agree to participate in this study, please consider how the study is designed and the potential risks and benefits so that you can make an informed decision. This process is called 'giving consent'.

The implantation procedure is identical in both groups, only the type of pressure bandage applied after the procedure is different.

SafeGuard FocusTM compression bandage:

If randomized to the study group, the SafeGuard FocusTM pressure bandage will be applied immediately after closing the skin according to the following steps:

Preparation: Clean and dry wound and surrounding skin Placement: Apply isobetadine gauze and transparent bandage. Apply SafeGuard FocusTM pressure bandage with balloon placed at CIED pocket.

Starting compression: Fill with 60ml of air. If bleeding persists, add an additional 5 mL each time until bleeding stops (maximum 120 mL).

Deflation Step 1 (after 2 hours): check incision and, if possible, remove 20mL of air Deflation Step 2 (after 4 hours): Check incision and, if possible, remove 20mL of air Deflation Step 3 (after 6 hours): Check incision and, if possible, remove 20mL of air SafeGuard FocusTM is then left on the wound without air until the patient is discharged Then apply a classic plaster

Classic pressure bandage:

If randomized to the control group, a classic pressure bandage will be applied to the pocket for 6 hours. Patients are followed up 2 and 4 hours after the procedure, the day after the procedure and 1 month after the procedure. No additional follow-up moments are required compared to implantations outside the current study.

Follow-up Patients were assessed 2, 4 and 6 hours after procedure, day after procedure and one month after procedure. They were also assessed during any visit in between deemed relevant by the investigator. All patients underwent standard device interrogations, chest radiography and echocardiogram on the day after CIED implantation.

Eligibility criteria: Inclusion Criteria:

* patients undergoing primo CIED implantation (pacemaker, internal cardiac defibrillator or cardiac resynchronization therapy)
* with a high bleeding risk (as defined by at least 1 of the following risk factors: age \> 75 years, heart failure, kidney failure, antithrombotic use (double antiaggregant therapy or anticoagulation

Exclusion Criteria:

* refusal to participate
* mental illness

Primary outcomes:
measure: pocket hematome
timeFrame: 24 hours
Secondary outcomes:
measure: pain score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Cardiology
state: Antwerp
Study officials:
References: