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Analysis of Hematoma Following Breast Surgery

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ClinicalTrials.gov Identifier: NCT03515525
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Alexandra Anker, University of Regensburg

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.

Condition or disease Intervention/treatment
Hematoma Postoperative Bleeding Diagnostic Test: Closed-suction drain fluid volume

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Review of Patient Records for Analysis of Postoperative Bleeding Following Breast Surgery
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : April 22, 2018
Actual Study Completion Date : April 22, 2018

Group/Cohort Intervention/treatment
Hematoma side
Drain secretion volume prior to revision surgery on the breast side affected by hematoma.
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.

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
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.




Primary Outcome Measures :
  1. Drain fluid volume [ Time Frame: 24 hours postoperatively ]
    The drain fluid volume in the breast affected by hematoma was compared to the non-hematoma side.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515525


Locations
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Germany
Department of Plastic Surgery, University Hospital of Regensburg
Regensburg, Germany, 93055
Sponsors and Collaborators
University of Regensburg

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Responsible Party: Dr. Alexandra Anker, Plastic surgery resident, University of Regensburg
ClinicalTrials.gov Identifier: NCT03515525     History of Changes
Other Study ID Numbers: 18-955-104
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Alexandra Anker, University of Regensburg:
Breast surgery
Closed-suction drains
Additional relevant MeSH terms:
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Hemorrhage
Hematoma
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications