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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | No preconditioning of the flap. | |
| Preconditioned group | Experimental | Preconditioning of the flap prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preconditioning | Procedure | Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of hypoperfused skin island | The percentage of hypoperfused skin island should be measured clinically after surgery | up to 7 days postoperatively |
| Skin oxygen saturation of distal flap | The skin oxygen saturation of distal flap is measured via laserdoppler | 1 day postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications | wound complications including need of surgical reoperation are assessed | up to 12 weeks postoperatively |
| VEGF expression in skin and muscle of flap | Laboratory examination of tissue specimen obtained during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehran Dadras, MD | Contact | +492343023560 | mehran.dadras@bergmannsheil.de | |
| Björn Behr, MD | Contact | +492343023443 | bjorn.behr@rub.de |
| Name | Affiliation | Role |
|---|---|---|
| Björn Behr, MD | Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum | Principal Investigator |
| Mehran Dadras, MD | Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil | Recruiting | Bochum | North Rhine-Westphalia | 44789 | Germany |
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Randomized control trial comparing no preconditioning to preconditioning.
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| once during surgery |
| Density of flap dermal vessels | Laboratory examination of tissue specimen obtained during surgery | once during surgery |