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Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Primary Purpose

Negative-Pressure Wound Therapy, Edema, Free Flap

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)
Sponsored by
Ulf Dornseifer, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Negative-Pressure Wound Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Technische Universität München

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Negative Pressure Wound Therapy

Conventional Dressing

Arm Description

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.

Patients receive a conventional dressing for the muscle flap including fatty gauze and cotton gauze.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 2, 2015
Last Updated
January 21, 2023
Sponsor
Ulf Dornseifer, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02526342
Brief Title
Impact of Negative Pressure Wound Therapy on Free Muscle Flaps
Official Title
Impact of Negative Pressure Wound Therapy on Free Muscle Flaps
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
July 18, 2016 (Actual)
Study Completion Date
July 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ulf Dornseifer, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative-Pressure Wound Therapy, Edema, Free Flap, Microcirculation, Macrocirculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Wound Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Dressing
Arm Type
No Intervention
Arm Description
Patients receive a conventional dressing for the muscle flap including fatty gauze and cotton gauze.
Intervention Type
Device
Intervention Name(s)
V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Dornseifer, M.D.
Organizational Affiliation
Bogenhausen Academic Hospital, Technische Universität München, Munich, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Technische Universität München
City
Munich
ZIP/Postal Code
81925
Country
Germany

12. IPD Sharing Statement

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Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

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