CClinicalTrials.gg
Status unknownNCT03190876Updated May 3, 2019

Seroma Prevention After Body Contouring Procedures

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

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Seroma
  • Abdominoplasty
  • Complication of Surgical Procedure

Browse trials for

Keywords

  • Drain usage
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Minors or patients with a designated health care proxy, revision surgeries, morbid obesity
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    Suction drain

    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

  • Active comparator
    Passive drain

    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

  • Active comparator
    No drain

    Conventional body contouring procedure, no application of drains

    Procedure: Variable drain usage

Interventions

  • ProcedureVariable drain usage

    Influence of drain usage on seroma formation rate

05

What researchers measure

Primary outcomes

  1. 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.

06

Study locations

1 of 1 sites recruiting
  • Department of Plastic Surgery, University Hospital of Regensburg
    Regensburg, Bayern 93053, Germany
    • Lukas Prantl, Prof. Dr. Dr. · Contact · lukas.prantl@ukr.de · 0049 941 782 3110
    • Alexandra Anker, Dr. med. univ. · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03190876
Lead sponsor
University of Regensburg
Responsible party
Dr. Alexandra Anker (Principal Investigator, University of Regensburg) — Principal investigator
First posted
Jun 19, 2017
Start date
Mar 1, 2017
Primary completion
Mar 1, 2022 (estimated)
Completion
Mar 1, 2022 (estimated)
Last update
May 3, 2019

Study contacts

Alexandra Anker, Dr. med. univ.
Contact
aanker@caritasstjosef.de
0049 941 782 3110

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion