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| Name | Class |
|---|---|
| BioElectronics Corporation | INDUSTRY |
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A monocentric interventional randomized placebo controlled trial evaluating the efficacy of the post surgical and wound care recovery kit.
It's a small device that consists of a thin metal ring that is placed on the skin surface, non-invasively. It's connected with a small battery. When the plastic tag is removed and the button is pushed the device is activated. Within the ring a Pulsed Electromagnetic Field is created. It influences the receptor-ligand binding at the cell surface and might improve wound healing by diminishing wound edema and inflammation. It possibly helps reducing the inflammatory reaction induced by surgery.
Patients will be treated for uni or bilateral inguinal hernias and at the end of surgery, at the time of bandage, a kit will be applied at the level of the incision. One group will at random receive a working device, the other half will have a kit without active electromagnetic field.
Postoperative analgesic consumption will be measured in a diary and pain and quality of life will be measured using Visual Analogue Scale and EuraHS-Quality Of Life questionnaires.
The aim of this study is to evaluate whether the placement of the device reduces the acute postoperative pain and whether it reduces the incidence of chronic groin pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active kit | Experimental | Patient receives an active kit with pulsed electromagnetic field over wound surface area. |
|
| non-active kit | Placebo Comparator | Patient receives a non-active kit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic field therapy device | Device | Therapy device for 1 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesic requirement after 1 week. | Evaluation through Questionnaires, VAS, euraHS QOL, diary. | 1 week after the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| chronic pain at 3 months post-surgery. | Clinical evaluation and VAS. | 3 months post surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederik Berrevoet, MD, PhD, FACS | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Non magnetic field therapy device. | Device | Non-active device for 1 week. |
|
|
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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