A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue.
Flap surgery relies on the perfusion of the transposed or transplanted tissue. Distal parts of flaps are at risk of ischemia leading to wound complications and reoperation. The potential benefit of a preconditioning protocol using foam mediated negative pressure on the flap before surgery is to be examined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Bochum, North Rhine-Westphalia, Germany
RECRUITINGPercentage of hypoperfused skin island
The percentage of hypoperfused skin island should be measured clinically after surgery
Time frame: up to 7 days postoperatively
Skin oxygen saturation of distal flap
The skin oxygen saturation of distal flap is measured via laserdoppler
Time frame: 1 day postoperative
Wound complications
wound complications including need of surgical reoperation are assessed
Time frame: up to 12 weeks postoperatively
VEGF expression in skin and muscle of flap
Laboratory examination of tissue specimen obtained during surgery
Time frame: once during surgery
Density of flap dermal vessels
Laboratory examination of tissue specimen obtained during surgery
Time frame: once during surgery
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