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.
Exclusion Criteria:
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
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University of Regensburg