Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Study Overview
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Brief Summary
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Aim of the study is to prove the utility and safety of the negative pressure wound therapy (NPWT) in the postoperative management of free flaps. The quantitative assessment of the entirety of clinical main relevant parameters like edema formation, microcirculation, macrocirculation and wound healing should create a better and comprehensive understanding of the NPWT effects in this field.

Detailed Description
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This study evaluates the impact of negative pressure wound therapy on free muscle flaps. Flaps were treated with NPWT or with a conventional dressing (control) for five days following tissue transfer. Edema formation is measured by a 3D scan (Artec SpiderTM) during the operation, five and fourteen days after surgery. The macrocirculation- and microcirculation parameters of the flaps are assessed using an implanted Doppler probe (Cook-Swartz®) as well as combined flowmetry and remission spectroscopy (O2C®). These measurements are conducted daily at the day of the operation as well as the first five days following the operation. Following dressing removal at the fifth postoperative day, skin graft take is assessed.

Official Title
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Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Conditions
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Negative-Pressure Wound Therapy, Edema, Free Flap, Microcirculation, Macrocirculation

Intervention / Treatment
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* Device: V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring free muscle flap reconstruction at the lower extremity covered with a split thickness skin graft existing cognitive faculty consent Exclusion Criteria: non-compliance non-consent

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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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Negative Pressure Wound Therapy<br>Patients receive a Negative Pressure Wound Therapy-Dressing (V.A.C. Ultra (KCI®,San Antonio, Texas, USA) with a subatmospheric pressure of 125mmHg to cover the muscle flap for five days following surgery. | Device: V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)<br>* Free muscle flaps are treated with Negative Pressure Wound Therapy (V.A.C. Ultra (KCI®,San Antonio, Texas, USA)) for five days following surgery with a continuous subatmospheric pressure of 125 mmHg.<br>|
| No Intervention: Conventional Dressing<br>Patients receive a conventional dressing for the muscle flap including fatty gauze and cotton gauze. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Flap Edema in the early postoperative period measured by a 3D Scan - Artec SpiderTM, Artec Group, Palo Alto, California, USA |  | Measurements were conducted at the day of the operation, five and fourteen days following surgery |