Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Edema Clinical Trial

Official title:

Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526342
• Other study ID #: KBogenhausen_04
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Edema
• Free Flap
• Macrocirculation
• Microcirculation
• Negative-Pressure Wound Therapy
• Wounds and Injuries

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