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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pocket compression fixation belt | Experimental | Pocket compression belt is used to compress the bleeding vessels and reduce bleeding after implantation. |
|
| Sand bag compression | Active Comparator | Sand bag compression is used to compress the bleeding vessels and reduce bleeding after implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pocket compression fixation belt | Device | Pocket compression fixation belt to is used to compress the postoperative wounds of CIEDS patients, and its effect of preventing hematoma is evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and grade of pocket hematoma | The incidence and grade of pocket hematoma between the control and experimental group were compared | 48 hours post implantation of ICEDs. |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time and positional adjustment of the sandbag | Operation time refer to the consuming minutes that perform compression procedure for each patient, including the total time to fix the salt bag and remove the salt bag twice during intermittent compression. | Accumulate the time used to place and adjust the salt bag within 48 hours for each patient. |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingwen Hu, Master | Contact | 008618991232872 | jingwenhu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingwen Hu, Master | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 23801827 |
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| Background |
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| 33675448 | Derived | Hu J, Zheng J, Liu X, Li G, Xiao X. Effect of a pocket compression device on hematomas, skin reactions, and comfort in patients receiving a cardiovascular implantable electronic device: a randomized controlled trial. J Interv Card Electrophysiol. 2022 Mar;63(2):275-281. doi: 10.1007/s10840-021-00973-5. Epub 2021 Mar 6. |