Ghent University Hospital
Ghent, 9000, Belgium
NCT Number: NCT01842204
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ghent, 9000, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Therapy device for 1 week.
Other names: Post-surgical and wound care recovery kit.
Non-active device for 1 week.
Other names: Post-surgical and Wound care recovery kit.
Time frame: 1 week after the surgery.
Evaluation through Questionnaires, VAS, euraHS QOL, diary.
Time frame: 3 months post surgery.
Clinical evaluation and VAS.
University Hospital, Ghent
Other
Acronym: ELEFANT
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