Pocket HematomaNCT06748573
Compression Device to Reduce Pocket Hematoma After Cardiac Implantable Electronic Device Implantation in a High Bleeding Risk Population
A study testing SafeGuard FocusTM compression bandage and Conventional bandage in people with Pocket Hematoma, run by Maxime Tijskens at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pocket Hematoma
- What is being tested?
- SafeGuard FocusTM compression bandage and Conventional bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- refusal to participate
- mental illness
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pocket Hematoma
- Being tested
- SafeGuard FocusTM compression bandage, Conventional bandage
- Keywords
- pocket hematoma, compression device, cardiac implantable electronic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeGuard FocusTM compression bandageDevice
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 bandageDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | conventional compression bandage Receives: Device: Conventional bandage |
| Study arm | Experimental | Study device (inflatable and see-through) Receives: Device: SafeGuard FocusTM compression bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
pocket hematome
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.
Measured: 24 hours
Secondary outcomes (1)
pain score
Visual Analog Scale (VAS) pain score (0-10/10 with 0 = no pain at all; 10= worst possible pain)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pocket HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxime Tijskens
- Sponsor type
- University, hospital or other
- Collaborators
- Merit Medical Systems, Inc.
- Responsible party
- Sponsor-investigator, Maxime Tijskens, Ziekenhuis aan de Stroom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748573
- Sponsor's protocol ID
- 5671
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can be shared at reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06748573
- Acronym / sponsor ID
- 5671
- Conditions
- Pocket Hematoma
- Keywords
- pocket hematoma, compression device, cardiac implantable electronic device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Maxime TijskensUniversity, hospital or other
- Collaborators
- Merit Medical Systems, Inc.
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Device: Conventional bandageconventional compression bandage |
| Study arm | Experimental | Device: SafeGuard FocusTM compression bandageStudy device (inflatable and see-through) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- refusal to participate
- mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafeGuard FocusTM compression bandageIf 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 | Study arm |
| Conventional bandageIf 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. | Device | Control arm |
Primary outcome
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.
1 secondary outcome
pain score
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. It can be shared at reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeGuard FocusTM compression bandage and Conventional bandage in people with Pocket Hematoma, run by Maxime Tijskens at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pocket hematome (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.