Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02526342

Enrollment

Registered

2015-08-18

Start date

2015-08-01

Completion date

2016-07-18

Last updated

2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DEVICEV.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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026