Analysis of Hematoma Following Breast Surgery

NCT03515525 | Completed

• 1 other identifier: 18-955-104
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematoma; Postoperative Bleeding

Keywords

Breast surgery; Closed-suction drains

Outcome Measures

Primary Outcomes (1)

• Drain fluid volume

  The drain fluid volume in the breast affected by hematoma was compared to the non-hematoma side.

  24 hours postoperatively

Study Arms (2)

Hematoma side

Drain secretion volume prior to revision surgery on the breast side affected by hematoma.

Diagnostic Test: Closed-suction drain fluid volume

Non-hematoma side

Drain secretion volume prior to revision surgery on the breast side not affected by hematoma.

Diagnostic Test: Closed-suction drain fluid volume

Interventions

Closed-suction drain fluid volume DIAGNOSTIC_TEST

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.

Hematoma side; Non-hematoma side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We enrolled 20 subjects who developed unilateral hematoma requiring evacuation following bilateral breast surgery between January 2008 and January 2018 at our institution. Gender, age, breast surgery subtype, preoperative and postoperative hemoglobin values as well as perioperative heparinization were recorded.

You may qualify if:

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

You may not qualify if:

• Patients who developed hematoma requiring revision following unilateral breast surgery.
• Breast surgery in absence of hematoma.
• Patients with known coagulation disorders.

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

Department of Plastic Surgery, University Hospital of Regensburg

Regensburg, 93055, Germany

Location

MeSH Terms

Conditions

Hematoma; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic surgery resident

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 3, 2018
• Study Start: March 1, 2018
• Primary Completion: April 22, 2018
• Study Completion: April 22, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)