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Completed

NCT Number: NCT06748573

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

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.

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Key information

Conditions

Pocket Hematoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology

Wilrijk, Antwerp, 2610, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SafeGuard FocusTM compression bandage

Device

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

Device

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.

Primary outcomes

  1. pocket hematome

    Time frame: 24 hours

    Grade I PH is defined as pocket ecchymosis or small effusion in the absence of swelling or pain. Grade II PH consists of large pocket effusion leading to swelling or pain. Grade III PH is characterized by the need of reoperation and/or hospitalization prolongation and/or interruption of antithrombotic drugs.

Secondary outcomes

  1. pain score

    Time frame: 24 hours

    Visual Analog Scale (VAS) pain score (0-10/10 with 0 = no pain at all; 10= worst possible pain)

Sponsors and collaborators

Lead sponsor

Maxime Tijskens

Other

Collaborators

  • Merit Medical Systems, Inc.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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