Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

NCT02526342 | Completed DMC

• 1 other identifier: KBogenhausen_04
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Negative-Pressure Wound Therapy; Edema; Free Flap; Microcirculation; Macrocirculation

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

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)

Conventional Dressing

NO INTERVENTION

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

Interventions

V.A.C. UltraTM (KCI®,San Antonio, Texas, USA) DEVICE

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.

Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non-compliance
• non-consent

Sponsors & Collaborators

• Ulf Dornseifer, MD: lead

Study Sites (1)

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

Munich, 81925, Germany

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Dornseifer, M.D.

  Bogenhausen Academic Hospital, Technische Universität München, Munich, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: August 2, 2015
• First Posted: August 18, 2015
• Study Start: August 1, 2015
• Primary Completion: July 18, 2016
• Study Completion: July 18, 2016
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

DE (1)