Negative-Pressure Wound TherapyNCT02526342
Impact of Negative Pressure Wound Therapy on Free Muscle Flaps
A study testing V.A.C. UltraTM (KCI®,San Antonio, Texas, USA) in people with Negative-Pressure Wound Therapy and Edema, run by Ulf Dornseifer, MD at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Negative-Pressure Wound Therapy, Edema, Free Flap
- What is being tested?
- V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2015to 18 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring free muscle flap reconstruction at the lower extremity covered with a split thickness skin graft
- existing cognitive faculty
- consent
Who cannot join
- non-compliance
- non-consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Technische Universität München
Munich, 81925
About this study
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.
Read the 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.
- Being tested
- V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Flap Edema in the early postoperative period measured by a 3D Scan - Artec SpiderTM, Artec Group, Palo Alto, California, USA
Measured: Measurements were conducted at the day of the operation, five and fourteen days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start1 Aug 2015
- Primary completion18 Jul 2016
- Study completion18 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative-Pressure Wound TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulf Dornseifer, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulf Dornseifer, MD, Klinik Bogenhausen
- Investigators
- Ulf Dornseifer, M.D., Principal investigator, Bogenhausen Academic Hospital, Technische Universität München, Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526342
- Sponsor's protocol ID
- KBogenhausen_04
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2015
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Negative Pressure Wound Therapy on Free Muscle Flaps
- ClinicalTrials.gov ID
- NCT02526342
- Acronym / sponsor ID
- KBogenhausen_04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ulf Dornseifer, MDUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 18 Jul 2016 (actual)
- Study completion
- 18 Jul 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Device: V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)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. |
| Conventional Dressing | No intervention | –Patients receive a conventional dressing for the muscle flap including fatty gauze and cotton gauze. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring free muscle flap reconstruction at the lower extremity covered with a split thickness skin graft
- existing cognitive faculty
- consent
Key exclusion criteria (2 listed)
- non-compliance
- non-consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Negative Pressure Wound Therapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Dornseifer, M.D. principal investigator
Bogenhausen Academic Hospital, Technische Universität München, Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V.A.C. UltraTM (KCI®,San Antonio, Texas, USA) in people with Negative-Pressure Wound Therapy and Edema, run by Ulf Dornseifer, MD at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.