SeromaNCT03190876
Seroma Prevention After Body Contouring Procedures
A study testing Variable drain usage in people with Seroma and Abdominoplasty, run by University of Regensburg at 1 site in Germany.
Trial summary
With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Seroma, Abdominoplasty, Complication of Surgical Procedure
- What is being tested?
- Variable drain usage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2017to 1 Mar 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All full-aged patients requiring body contouring procedures in our department who provide oral and written informed consent indicating that they agree to participate in the study
Who cannot join
- Minors or patients with a designated health care proxy, revision surgeries, morbid obesity
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Plastic Surgery, University Hospital of Regensburg
Regensburg, Bavaria, 93053
Lukas Prantl, Prof. Dr. Dr., 0049 941 782 3110, lukas.prantl@ukr.de
Alexandra Anker, Dr. med. univ.
About this study
Official title: Prevention of Seroma Formation After Body Contouring Procedures
With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.
- Conditions
- Seroma, Abdominoplasty, Complication of Surgical Procedure
- Being tested
- Variable drain usage
- Keywords
- Drain usage
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable drain usageProcedure or surgery
Influence of drain usage on seroma formation rate
| Study group | Role | What they receive |
|---|---|---|
| Suction drain | No intervention | Conventional body contouring procedure, application of Redon suction drains, drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7 |
| Passive drain | Active comparator | Conventional body contouring procedure, application of drains without suction (passive drainage), drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7 Receives: Procedure: Variable drain usage |
| No drain | Active comparator | Conventional body contouring procedure, no application of drains Receives: Procedure: Variable drain usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of seroma formation
As primary outcome this study measures the rate of seroma requiring evacuation via puncture aspiration (fluid retention > 20 cc) in each group.
Measured: Weekly follow-up until postoperative week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexandra Anker, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190876
- Sponsor's protocol ID
- 16-101-0292
- Status last verified
- May 2019
- First submitted
- 15 Jun 2017
- Last updated
- 3 May 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 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Seroma Formation After Body Contouring Procedures
- ClinicalTrials.gov ID
- NCT03190876
- Acronym / sponsor ID
- 16-101-0292
- Conditions
- Seroma, Abdominoplasty, Complication of Surgical Procedure
- Keywords
- Drain usage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 19 Jun 2017 (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.
With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suction drain | No intervention | –Conventional body contouring procedure, application of Redon suction drains, drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7 |
| Passive drain | Active comparator | Procedure: Variable drain usageConventional body contouring procedure, application of drains without suction (passive drainage), drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7 |
| No drain | Active comparator | Procedure: Variable drain usageConventional body contouring procedure, no application of drains |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All full-aged patients requiring body contouring procedures in our department who provide oral and written informed consent indicating that they agree to participate in the study
Key exclusion criteria (1 listed)
- Minors or patients with a designated health care proxy, revision surgeries, morbid obesity
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 |
|---|---|---|
| Variable drain usageInfluence of drain usage on seroma formation rate | Procedure or surgery | No drain, Passive drain |
Primary outcome
Rate of seroma formation
Time frame: Weekly follow-up until postoperative week 6.
As primary outcome this study measures the rate of seroma requiring evacuation via puncture aspiration (fluid retention > 20 cc) in each group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable drain usage in people with Seroma and Abdominoplasty, run by University of Regensburg 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 3 May 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 Alexandra Anker, Dr. med. univ. (0049 941 782 3110, aanker@caritasstjosef.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of seroma formation (time frame: Weekly follow-up until postoperative week 6.). 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 3 May 2019.