Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Ulf Dornseifer, MD

Status: Completed

Conditions: Edema; Negative-Pressure Wound Therapy; Microcirculation; Macrocirculation; Free Flap

Treatments: Device: V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02526342

KBogenhausen_04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Negative Pressure Wound Therapy

Active Comparator group

Description:

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.

Treatment:

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

Conventional Dressing

No Intervention group

Description:

Patients receive a conventional dressing for the muscle flap including fatty gauze and cotton gauze.