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Clinical Trials/NCT02526342
NCT02526342
Completed
Not Applicable

Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Ulf Dornseifer, MD1 site in 1 country26 target enrollmentAugust 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Negative-Pressure Wound Therapy
Sponsor
Ulf Dornseifer, MD
Enrollment
26
Locations
1
Primary Endpoint
Change of Flap Edema in the early postoperative period measured by a 3D Scan - Artec SpiderTM, Artec Group, Palo Alto, California, USA
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2015
End Date
July 18, 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ulf Dornseifer, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Ulf Dornseifer, MD

Dr.med.

Klinik Bogenhausen

Eligibility Criteria

Inclusion Criteria

  • Patients requiring free muscle flap reconstruction at the lower extremity covered with a split thickness skin graft
  • existing cognitive faculty

Exclusion Criteria

  • non-compliance
  • non-consent

Outcomes

Primary Outcomes

Change of Flap Edema in the early postoperative period measured by a 3D Scan - Artec SpiderTM, Artec Group, Palo Alto, California, USA

Time Frame: Measurements were conducted at the day of the operation, five and fourteen days following surgery

Study Sites (1)

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