Analysis of Hematoma Following Breast Surgery

Hematoma Clinical Trial

Official title:

Retrospective Review of Patient Records for Analysis of Postoperative Bleeding Following Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515525
• Other study ID #: 18-955-104
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: April 22, 2018

Study information

• Verified date: April 2018
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective review of patients who developed hematoma following breast surgery from 2003 to 2018 in a single institution was performed. The study investigated the value of closed-suction drains regarding the quantity and quality of fluid secretion for the prediction of subcutaneous hematoma in patients undergoing breast surgery procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 22, 2018
• Est. primary completion date: April 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who developed hematoma requiring revision following bilateral breast surgery including augmentation mammoplasty, subcutaneous mastectomy and breast reduction.

Exclusion Criteria:

• Patients who developed hematoma requiring revision following unilateral breast surgery.

• Breast surgery in absence of hematoma.

• Patients with known coagulation disorders.

Related Conditions & MeSH terms

• Hematoma
• Hemorrhage
• Postoperative Bleeding
• Postoperative Hemorrhage

Intervention

Diagnostic Test:
• Closed-suction drain fluid volume
To evaluate the clinical value of postoperative drain fluid volume for detection of hematoma, an intra-individual comparison of drain secretion volumes between sides affected by hematoma and the uneventful contralateral breasts was performed.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drain fluid volume	The drain fluid volume in the breast affected by hematoma was compared to the non-hematoma side.	24 hours postoperatively