HematomaNCT03515525
Analysis of Hematoma Following Breast Surgery
An observational study of Hematoma and Postoperative Bleeding, run by University of Regensburg at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematoma, Postoperative Bleeding
- What is being tested?
- Closed-suction drain fluid volume
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 22 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients who developed hematoma requiring revision following bilateral breast surgery including augmentation mammoplasty, subcutaneous mastectomy and breast reduction.
Who cannot join
- Patients who developed hematoma requiring revision following unilateral breast surgery.
- Breast surgery in absence of hematoma.
- Patients with known coagulation disorders.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Plastic Surgery, University Hospital of Regensburg
Regensburg, 93055
About this study
Official title: Retrospective Review of Patient Records for Analysis of Postoperative Bleeding Following Breast Surgery
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
- Being tested
- Closed-suction drain fluid volume
- Keywords
- Breast surgery, Closed-suction drains
- Medical subject headings
- Hematoma, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-suction drain fluid volumeDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Hematoma side | Drain secretion volume prior to revision surgery on the breast side affected by hematoma. Receives: 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. Receives: Diagnostic Test: Closed-suction drain fluid volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain fluid volume
The drain fluid volume in the breast affected by hematoma was compared to the non-hematoma side.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start1 Mar 2018
- Primary completion22 Apr 2018
- Study completion22 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexandra Anker, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515525
- Sponsor's protocol ID
- 18-955-104
- Status last verified
- Apr 2018
- First submitted
- 22 Apr 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Patient Records for Analysis of Postoperative Bleeding Following Breast Surgery
- ClinicalTrials.gov ID
- NCT03515525
- Acronym / sponsor ID
- 18-955-104
- Conditions
- Hematoma, Postoperative Bleeding
- Keywords
- Breast surgery, Closed-suction drains
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 22 Apr 2018 (actual)
- Study completion
- 22 Apr 2018 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematoma side | – | Diagnostic Test: Closed-suction drain fluid volumeDrain secretion volume prior to revision surgery on the breast side affected by hematoma. |
| Non-hematoma side | – | Diagnostic Test: Closed-suction drain fluid volumeDrain secretion volume prior to revision surgery on the breast side not affected by hematoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who developed hematoma requiring revision following bilateral breast surgery including augmentation mammoplasty, subcutaneous mastectomy and breast reduction.
Key exclusion criteria (3 listed)
- Patients who developed hematoma requiring revision following unilateral breast surgery.
- Breast surgery in absence of hematoma.
- Patients with known coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-suction drain fluid volumeTo 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. | Diagnostic test | Hematoma side, Non-hematoma side |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematoma and Postoperative Bleeding, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drain fluid volume (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.