An interventional study of Variable drain usage in Seroma, Abdominoplasty and Complication of Surgical Procedure, sponsored by University of Regensburg. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-03.
Sponsored by University of Regensburg · Not applicable, Interventional, and Prevention
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.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →University of Regensburg is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Procedure: Variable drain usage
Conventional body contouring procedure, no application of drains
Procedure: Variable drain usage
Influence of drain usage on seroma formation rate
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.
Time frame: Weekly follow-up until postoperative week 6.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2017 (actual). Primary completion is estimated for Mar 2022, 60 months after the start.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's planned 60 months is above that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University of Regensburg