Back to resultsSeroma Prevention After Body Contouring Procedures
Primary Purpose
Seroma, Abdominoplasty, Complication of Surgical Procedure
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Variable drain usage
Sponsored by
About this trial
This is an interventional prevention trial for Seroma focused on measuring Drain usage
Eligibility Criteria
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:
- Minors or patients with a designated health care proxy, revision surgeries, morbid obesity
Sites / Locations
- Department of Plastic Surgery, University Hospital of RegensburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Suction drain
Passive drain
No drain
Arm Description
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
Conventional body contouring procedure, no application of drains
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03190876
Brief Title
Seroma Prevention After Body Contouring Procedures
Official Title
Prevention of Seroma Formation After Body Contouring Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma, Abdominoplasty, Complication of Surgical Procedure
Keywords
Drain usage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Suction drain
Arm Type
No Intervention
Arm Description
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
Arm Title
Passive drain
Arm Type
Active Comparator
Arm Description
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
Arm Title
No drain
Arm Type
Active Comparator
Arm Description
Conventional body contouring procedure, no application of drains
Intervention Type
Procedure
Intervention Name(s)
Variable drain usage
Intervention Description
Influence of drain usage on seroma formation rate
Primary Outcome Measure Information:
Title
Rate of seroma formation
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Minors or patients with a designated health care proxy, revision surgeries, morbid obesity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Anker, Dr. med. univ.
Phone
0049 941 782 3110
Email
aanker@caritasstjosef.de
Facility Information:
Facility Name
Department of Plastic Surgery, University Hospital of Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas Prantl, Prof. Dr. Dr.
Phone
0049 941 782 3110
Email
lukas.prantl@ukr.de
First Name & Middle Initial & Last Name & Degree
Alexandra Anker, Dr. med. univ.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Seroma Prevention After Body Contouring Procedures
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