Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Not Applicable

Completed

• Conditions: Edema; Microcirculation; Macrocirculation; Negative-Pressure Wound Therapy; Free Flap
• Interventions: Device: V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)

• Registration Number: NCT02526342
• Lead Sponsor: Ulf Dornseifer, MD

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.

Study Timeline

• Study Start: 2015-08-01
• Study First Submitted: 2015-08-02
• Study First Submitted QC: 2015-08-15
• Study First Posted: 2015-08-18
• Primary Completion: 2016-07-18
• Study Completion: 2016-07-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy	V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Technische Universität München; 🇩🇪 Munich, Germany