Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices

Xi'an Jiaotong University

Status: Unknown

Conditions: Cardiac Resynchronization Therapy Devices; Hematoma Postoperative; Compression Bandages

Treatments: Device: pocket compression fixation belt

Study type: Interventional

Funder types: Other

Identifiers

NCT04389398

XJTU1AF2020LSK-040

Details and patient eligibility

About

As the number of implanted cardiovascular implanted electronic devices (CIEDs) increases, the incidence of their complications also grows. Pocket hematoma is an important complication of CIED implantation, which has been reported in 2.9-9.5% of CIEDs patients. Pocket hematoma can cause significant pain and interfere with proper wound healing, and it also increased the risk of infection and may prolong length of stay.

Pocket compression is usually applied to compress bleeding vessels and reduce bleeding after implantation. A conventional compression method is to place a sandbag over the pocket, and then using adhesive tape to fix the sandbag. Due to adhesive tape is elastic and the tape may be pulled by patients' activity, sandbag easily migrated from the site. Therefore, nurse must readjust the position of sandbag, or even remove the adhesive tape and perform re-compress. Furthermore, adhesive tape can cause skin erosion. All of which not only result in patients' discomfort and dissatisfaction, but also increase the burden on nurses and wastes resources.

We designed a pocket compression fixation belt. We assumed that using this fixation belt can ensure the compression effect while avoiding sand bag displacement, reducing skin erosion and decrease the workload of care.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Registry of patients undergoing PM, ICD, and CRT-P or CRT-D device implantation in The First Affiliated Hospital of Xi'an Jiaotong University.

Exclusion criteria

• (1) age<18 years or >80 years, (2) a history of any psychiatric illness, (3) a history of open wounds in the infraclavicular region, (4) coagulation disorder or bleeding diathesis, (5) anticoagulation or antithrombotic treatments could not be interrupted, (6) refusing to participate. This study was approved by the Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (approval number XJTU1AF2020LSK-040).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Pocket compression fixation belt

Experimental group

Description:

Pocket compression belt is used to compress the bleeding vessels and reduce bleeding after implantation.

Treatment:

Device: pocket compression fixation belt

Sand bag compression

Active Comparator group

Description:

Sand bag compression is used to compress the bleeding vessels and reduce bleeding after implantation.

Treatment:

Device: pocket compression fixation belt