Flap Preconditioning by Intermittent Negative Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lappenpräkonditionierung Durch Intermittierende Negative Drucktherapie - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie

Conditions
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Complication of Surgical Procedure, Flap Ischemia

Intervention / Treatment
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* Procedure: Preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning. Exclusion Criteria: Infection of skin of planned flap.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial comparing no preconditioning to preconditioning.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No preconditioning of the flap. | |
| Experimental: Preconditioned group<br>Preconditioning of the flap prior to surgery. | Procedure: Preconditioning<br>* Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | once during surgery | 
| Density of flap dermal vessels | Laboratory examination of tissue specimen obtained during surgery | once during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flap preconditioning