Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Sponsor
Ulf Dornseifer, MD (Other)
Overall Status
Unknown status
CT.gov ID
NCT02526342
Collaborator
(none)
30
1
2
13
2.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Negative Pressure Wound Therapy on Free Muscle Flaps
Study Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2016
Anticipated Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Negative Pressure Wound Therapy

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.

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.

No Intervention: Conventional Dressing

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

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Technische Universität München Munich Germany 81925

Sponsors and Collaborators

  • Ulf Dornseifer, MD

Investigators

  • Principal Investigator: Ulf Dornseifer, M.D., Bogenhausen Academic Hospital, Technische Universität München, Munich, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ulf Dornseifer, MD, Dr.med., Klinik Bogenhausen
ClinicalTrials.gov Identifier:
NCT02526342
Other Study ID Numbers:
  • KBogenhausen_04
First Posted:
Aug 18, 2015
Last Update Posted:
May 17, 2016
Last Verified:
May 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2016