Seroma Prevention After Body Contouring Procedures
Prevention of Seroma Formation After Body Contouring Procedures
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMay 3, 2019
May 1, 2019
5 years
June 15, 2017
May 1, 2019
Conditions
Keywords
Outcome Measures
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.
Weekly follow-up until postoperative week 6.
Study Arms (3)
Suction drain
NO INTERVENTIONConventional 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 COMPARATORConventional 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 COMPARATORConventional body contouring procedure, no application of drains
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Minors or patients with a designated health care proxy, revision surgeries, morbid obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Plastic Surgery, University Hospital of Regensburg
Regensburg, Bavaria, 93053, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 15, 2017
First Posted
June 19, 2017
Study Start
March 1, 2017
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
May 3, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share