Seroma Prevention After Body Contouring Procedures

University of Regensburg (UR)

Status: Unknown

Conditions: Complication of Surgical Procedure; Seroma; Abdominoplasty

Treatments: Procedure: Variable drain usage

Study type: Interventional

Funder types: Other

Identifiers

NCT03190876

16-101-0292

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Suction drain

No Intervention group

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

Passive drain

Active Comparator group

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

Treatment:

Procedure: Variable drain usage

No drain

Active Comparator group

Description:

Conventional body contouring procedure, no application of drains

Treatment:

Procedure: Variable drain usage