Complication of Surgical ProcedureNCT03900065
Flap Preconditioning by Intermittent Negative Pressure
A study testing Preconditioning in people with Complication of Surgical Procedure and Flap Ischemia, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Surgical Procedure, Flap Ischemia
- What is being tested?
- Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 1 Jul 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning.
Who cannot join
- Infection of skin of planned flap.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Bochum, North Rhine-Westphalia, 44789
Mehran Dadras, MD, +492343023560, mehran.dadras@bergmannsheil.de
Björn Behr, MD, +492343023443, bjorn.behr@rub.de
About this study
Official title: Lappenpräkonditionierung Durch Intermittierende Negative Drucktherapie - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue.
Read the detailed description
Flap surgery relies on the perfusion of the transposed or transplanted tissue. Distal parts of flaps are at risk of ischemia leading to wound complications and reoperation. The potential benefit of a preconditioning protocol using foam mediated negative pressure on the flap before surgery is to be examined.
- Conditions
- Complication of Surgical Procedure, Flap Ischemia
- Being tested
- Preconditioning
- Keywords
- flap preconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreconditioningProcedure or surgery
Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No preconditioning of the flap. |
| Preconditioned group | Experimental | Preconditioning of the flap prior to surgery. Receives: Procedure: Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of hypoperfused skin island
The percentage of hypoperfused skin island should be measured clinically after surgery
Measured: up to 7 days postoperatively
Skin oxygen saturation of distal flap
The skin oxygen saturation of distal flap is measured via laserdoppler
Measured: 1 day postoperative
Secondary outcomes (3)
Wound complications
wound complications including need of surgical reoperation are assessed
Measured: up to 12 weeks postoperatively
VEGF expression in skin and muscle of flap
Laboratory examination of tissue specimen obtained during surgery
Measured: once during surgery
Density of flap dermal vessels
Laboratory examination of tissue specimen obtained during surgery
Measured: once during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Jan 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies 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
- Model description
- Randomized control trial comparing no preconditioning to preconditioning.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehran Dadras, MD, Ruhr University of Bochum
- Investigators
- Björn Behr, MD, Principal investigator, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil BochumMehran Dadras, MD, Study director, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900065
- Sponsor's protocol ID
- 18-6408-BR
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lappenpräkonditionierung Durch Intermittierende Negative Drucktherapie - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
- ClinicalTrials.gov ID
- NCT03900065
- Acronym / sponsor ID
- 18-6408-BR
- Conditions
- Complication of Surgical Procedure, Flap Ischemia
- Keywords
- flap preconditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 2 Apr 2019 (actual)
- 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.
A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue.
Detailed description
Flap surgery relies on the perfusion of the transposed or transplanted tissue. Distal parts of flaps are at risk of ischemia leading to wound complications and reoperation. The potential benefit of a preconditioning protocol using foam mediated negative pressure on the flap before surgery is to be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial comparing no preconditioning to preconditioning.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No preconditioning of the flap. |
| Preconditioned group | Experimental | Procedure: PreconditioningPreconditioning of the flap prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning.
Key exclusion criteria (1 listed)
- Infection of skin of planned flap.
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 |
|---|---|---|
| PreconditioningFoam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery. | Procedure or surgery | Preconditioned group |
Primary outcome
Percentage of hypoperfused skin island
Time frame: up to 7 days postoperatively
The percentage of hypoperfused skin island should be measured clinically after surgery
Skin oxygen saturation of distal flap
Time frame: 1 day postoperative
The skin oxygen saturation of distal flap is measured via laserdoppler
3 secondary outcomes
Wound complications
Time frame: up to 12 weeks postoperatively
VEGF expression in skin and muscle of flap
Time frame: once during surgery
Density of flap dermal vessels
Time frame: once during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Björn Behr, MD principal investigator
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
Mehran Dadras, MD study director
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preconditioning in people with Complication of Surgical Procedure and Flap Ischemia, run by Ruhr University of Bochum 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehran Dadras, MD (+492343023560, mehran.dadras@bergmannsheil.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of hypoperfused skin island (time frame: up to 7 days postoperatively). The study lists 2 primary outcomes in all. 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 2 Apr 2019.