Seroma Prevention After Body Contouring Procedures

Complication of Surgical Procedure Clinical Trial

Official title:

Prevention of Seroma Formation After Body Contouring Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03190876
• Other study ID #: 16-101-0292
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominoplasty
• Complication of Surgical Procedure
• Seroma

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.