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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02526342
Other study ID # KBogenhausen_04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2015
Est. completion date July 18, 2016

Study information

Verified date January 2023
Source Klinik Bogenhausen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 18, 2016
Est. primary completion date July 18, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
Germany Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Technische Universität München Munich

Sponsors (1)

Lead Sponsor Collaborator
Ulf Dornseifer, MD

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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