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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03190876
Other study ID # 16-101-0292
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date March 1, 2022

Study information

Verified date May 2019
Source University of Regensburg
Contact Alexandra Anker, Dr. med. univ.
Phone 0049 941 782 3110
Email aanker@caritasstjosef.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Variable drain usage
Influence of drain usage on seroma formation rate

Locations

Country Name City State
Germany Department of Plastic Surgery, University Hospital of Regensburg Regensburg Bayern

Sponsors (1)

Lead Sponsor Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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