NCT02526342

Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ulf Dornseifer, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Negative-Pressure Wound Therapy
• Edema
• Free Flap
• Microcirculation
• Macrocirculation

Interventions

Type	Name	Description
DEVICE	V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)	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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-07-18
• Completion: 2016-07-18
• First posted: 2015-08-18
• Last updated: 2023-01-25

Locations

1 site across 1 country: Germany