Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

NCT ID: NCT02526342

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2016-07-18

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Conventional Dressing

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ulf Dornseifer, MD

OTHER

Sponsor Role: lead

Responsible Party

Ulf Dornseifer, MD

Dr.med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ulf Dornseifer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bogenhausen Academic Hospital, Technische Universität München, Munich, Germany

Locations

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

Munich, , Germany

Countries

Germany

Other Identifiers

KBogenhausen_04

Identifier Type: -

Identifier Source: org_study_id