Breast HaematomaNCT05665894
Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis
An observational study of Breast Haematoma and Breast Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Among postoperative complications in breast surgery, hematoma is the most common occurrence. While mostly self-limited, in some cases surgical revision is mandatory when hematoma occurs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Haematoma, Breast Cancer, Breast Diseases
- What is being tested?
- Hematoma Vaacum Assisted Biopsy
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 15 Dec 2022
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: All female patients that developed postoperative or postoprocedural breast hematoma which do not requires urgent surgical procedure.
Who may be able to join
- age between 18 and 75 years old after breast conservative surgery (BCS), VAB or vacuum-assisted excision (VAE) procedure
- Clinically significant and large hematoma (>25 mm) that do not fulfill the criteria for immediate surgery and cause discomfort, pressure symptoms, infection, or pain classified on VAS > 3.
- Failure of attempt with FNA
- Patients that refuse surgery
Who cannot join
- pregnancy
- patients requiring urgent surgery
- Patient follow-up discontinued in our facility
- Symptomatic post-BCS early hematoma
Trial locations and contacts
1 site in 1 country.
About this study
Among postoperative complications in breast surgery, hematoma is the most common occurrence. While mostly self-limited, in some cases surgical revision is mandatory when hematoma occurs. Among percutaneous procedures, preliminary studies demonstrated the efficacy of vacuum-assisted breast biopsy(VAB) in evacuating breast hematomas. The aim of the present study is to investigate the efficacy of VAB system in evacuating hematoma, symptoms resolution, and avoidance of surgery.
From January 2016 to January 2020 ≥25 mm symptomatic breast hematoma after breast conserving surgery(BCS) and percutaneous procedures were retrospectively enrolled from a perspective maintained database. Preoperative demographic and clinical data were collected. Hematoma maximum diameter, Estimated hematoma volume, total procedure time, and visual analog scale (VAS) score prior ultrasound(US) Vacuum-Assisted Evacuation (VAEv) were recorded. At one week VAS score, residual hematoma volume, and complications were recorded. Study outcomes were defined as clearance of ≥70% postoperative hematoma, symptoms resolution (assessed as patient report visual analog scale (VAS≤3)), and avoidance of surgery during follow-up.
Read the detailed description
A monocentric, retrospective study from a prospectively maintained database was planned to evaluate the clinical outcome of patients undergoing VAB procedures for postoperative breast hematoma between 1st January 2016 and 1st January 2020.
Once breast hematoma is diagnosed and FNA did not obtain a complete clearance of the hematoma, in our clinical practice VAEv procedure is planned between 10-14 days from the first procedure (surgery, VAB, VAE). All VAEv procedures are performed in our outpatient department by a radiologist with > 10 years of experience in breast imaging and US-guided procedures.
Preoperative assessment is carried out just prior VAEv with high-resolution ultrasound (US) equipment (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) and with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy). The patient was placed supine and meticulous aseptic measures were applied. Prior procedure local anesthesia (lidocaine 1%) was administered following disinfection. A 5 mm skin incision is performed to guarantee appropriate access for the needle insertion in the hematomas. The evacuation was achieved using a Mammotome® vacuum-assisted system (Devicor Medical Products, Inc., Cincinnati, OH, USA), with an 8-G needle, under the guidance of the same high-resolution US equipment (MyLabTM 9 XP; Esaote SpA, Genoa) for preoperative assessment. Empty-needle function and the tissue-biopsy option is preferred to fragment the fibrotic tissue until the hematoma empties and its walls collapsed. Once VAEv is performed, the postoperative US is carried out and VAEv is repeated until more than 90% evacuations of hematoma volume if no complication occurs.
If the hematoma occurred after the percutaneous procedure (VAB, VAE), a new metal clip is placed in the site of the procedure to locate target breast lesion. At the end of the procedure, the hematoma site is then manually compressed for 5-10 min. Finally, the surgical site is covered with dressings and locoregional ice therapy was applied. Usually, after VAEv patients were observed in our outpatient clinic for 3 hours after the procedure prior to home discharge.
All patients were advised to wear tight sports-brassiere was recommended for a minimum of 24 hours to prevent rebleeding or major seroma formation. After VAEv patients are educated regarding our telephonic follow-up for any symptoms onset and are routinely re-evaluated at 1 week with US examination (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy), VAS assessment, and postoperative complications. Further telephonic follow-up evaluation is routinely scheduled to avoid late symptomatic breast hematoma underestimation.
- Conditions
- Breast Haematoma, Breast Cancer, Breast Diseases
- Being tested
- Hematoma Vaacum Assisted Biopsy
- Keywords
- Breast Neoplasm, Breast Hematoma, Breast Diseases, Vaacum assisted biopsy
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematoma Vaacum Assisted BiopsyDevice
Also called Hematoma Core needle biopsy
The patient was placed supine and meticulous aseptic measures were applied. Prior procedure local anesthesia (lidocaine 1%) was administered following disinfection. A 5 mm skin incision is performed to guarantee appropriate access for the needle insertion in the hematomas. The evacuation was achieved using a Mammotome® vacuum-assisted system (Devicor Medical Products, Inc., Cincinnati, OH, USA), with an 8-G needle, under the guidance of the same high-resolution US equipment (MyLabTM 9 XP; Esaote SpA, Genoa) for preoperative assessment. Empty-needle function and the tissue-biopsy option is preferred to fragment the fibrotic tissue until the hematoma empties and its walls collapsed. Once VAEv is performed, the postoperative US is carried out and VAEv is repeated until more than 90% evacuations of hematoma volume if no complication occurs.
| Study group | Role | What they receive |
|---|---|---|
| Breast hematoma group | Patients of age between 18 and 75 years old after breast conservative surgery (BCS), VAB or vacuum-assisted excision (VAE) procedure in our facility, who developed clinically significant and large hematoma (>25 mm). In our institution, we routinely offer a trial of Vacuum-Assisted Evacuation (VAEv) for >25 mm hematoma that does not fulfill the criteria for immediate surgery and causes discomfort, pressure symptoms, infection, or pain classified on VAS > 3. Receives: Device: Hematoma Vaacum Assisted Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma vacuum assisted biopsy success rate I
Clearance of ≥70% postoperative hematoma
Measured: At the end of the procedure
Symptom Resolution
Patient report visual analog scale (VAS) ≤3 (minimum 0; maximum 10) at the end of Hematoma vacuum assisted biopsy
Measured: At the end of the procedure
Hematoma vacuum assisted biopsy success rate I
Avoidance of surgery during follow-up for any reason
Measured: 30 days from the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Oct 2022
- Primary completion15 Nov 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast HaematomaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Materazzo, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665894
- Sponsor's protocol ID
- BREAST HEMATOMA
- Status last verified
- Dec 2022
- First submitted
- 17 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Almasarweh S, Sudah M, Joukainen S, Okuma H, Vanninen R, Masarwah A. The feasibility of ultrasound-guided vacuum-assisted evacuation of large breast hematomas. Radiol Oncol. 2020 Jun 26;54(3):311-316. doi: 10.2478/raon-2020-0041.
PubMed 32598321Guzman-Aroca F, Berna-Serna JD, Garcia-Ortega AA, Hernandez-Gomez D, Berna-Mestre JD. A New Management Technique for Symptomatic Haematomas Following Therapeutic Vacuum-Assisted Biopsy. J Clin Med. 2019 Sep 19;8(9):1493. doi: 10.3390/jcm8091493.
PubMed 31546843
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05665894
- Acronym / sponsor ID
- BREAST HEMATOMA
- Conditions
- Breast Haematoma, Breast Cancer, Breast Diseases
- Keywords
- Breast Neoplasm, Breast Hematoma, Breast Diseases, Vaacum assisted biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 27 Dec 2022 (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.
Among postoperative complications in breast surgery, hematoma is the most common occurrence. While mostly self-limited, in some cases surgical revision is mandatory when hematoma occurs. Among percutaneous procedures, preliminary studies demonstrated the efficacy of vacuum-assisted breast biopsy(VAB) in evacuating breast hematomas. The aim of the present study is to investigate the efficacy of VAB system in evacuating hematoma, symptoms resolution, and avoidance of surgery.
From January 2016 to January 2020 ≥25 mm symptomatic breast hematoma after breast conserving surgery(BCS) and percutaneous procedures were retrospectively enrolled from a perspective maintained database. Preoperative demographic and clinical data were collected. Hematoma maximum diameter, Estimated hematoma volume, total procedure time, and visual analog scale (VAS) score prior ultrasound(US) Vacuum-Assisted Evacuation (VAEv) were recorded. At one week VAS score, residual hematoma volume, and complications were recorded. Study outcomes were defined as clearance of ≥70% postoperative hematoma, symptoms resolution (assessed as patient report visual analog scale (VAS≤3)), and avoidance of surgery during follow-up.
Detailed description
A monocentric, retrospective study from a prospectively maintained database was planned to evaluate the clinical outcome of patients undergoing VAB procedures for postoperative breast hematoma between 1st January 2016 and 1st January 2020.
Once breast hematoma is diagnosed and FNA did not obtain a complete clearance of the hematoma, in our clinical practice VAEv procedure is planned between 10-14 days from the first procedure (surgery, VAB, VAE). All VAEv procedures are performed in our outpatient department by a radiologist with > 10 years of experience in breast imaging and US-guided procedures.
Preoperative assessment is carried out just prior VAEv with high-resolution ultrasound (US) equipment (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) and with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy). The patient was placed supine and meticulous aseptic measures were applied. Prior procedure local anesthesia (lidocaine 1%) was administered following disinfection. A 5 mm skin incision is performed to guarantee appropriate access for the needle insertion in the hematomas. The evacuation was achieved using a Mammotome® vacuum-assisted system (Devicor Medical Products, Inc., Cincinnati, OH, USA), with an 8-G needle, under the guidance of the same high-resolution US equipment (MyLabTM 9 XP; Esaote SpA, Genoa) for preoperative assessment. Empty-needle function and the tissue-biopsy option is preferred to fragment the fibrotic tissue until the hematoma empties and its walls collapsed. Once VAEv is performed, the postoperative US is carried out and VAEv is repeated until more than 90% evacuations of hematoma volume if no complication occurs.
If the hematoma occurred after the percutaneous procedure (VAB, VAE), a new metal clip is placed in the site of the procedure to locate target breast lesion. At the end of the procedure, the hematoma site is then manually compressed for 5-10 min. Finally, the surgical site is covered with dressings and locoregional ice therapy was applied. Usually, after VAEv patients were observed in our outpatient clinic for 3 hours after the procedure prior to home discharge.
All patients were advised to wear tight sports-brassiere was recommended for a minimum of 24 hours to prevent rebleeding or major seroma formation. After VAEv patients are educated regarding our telephonic follow-up for any symptoms onset and are routinely re-evaluated at 1 week with US examination (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy), VAS assessment, and postoperative complications. Further telephonic follow-up evaluation is routinely scheduled to avoid late symptomatic breast hematoma underestimation.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast hematoma group | – | Device: Hematoma Vaacum Assisted BiopsyPatients of age between 18 and 75 years old after breast conservative surgery (BCS), VAB or vacuum-assisted excision (VAE) procedure in our facility, who developed clinically significant and large hematoma (>25 mm). In our institution, we routinely offer a trial of Vacuum-Assisted Evacuation (VAEv) for >25 mm hematoma that does not fulfill the criteria for immediate surgery and causes discomfort, pressure symptoms, infection, or pain classified on VAS > 3. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All female patients that developed postoperative or postoprocedural breast hematoma which do not requires urgent surgical procedure.
Key inclusion criteria (4 listed)
- age between 18 and 75 years old after breast conservative surgery (BCS), VAB or vacuum-assisted excision (VAE) procedure
- Clinically significant and large hematoma (>25 mm) that do not fulfill the criteria for immediate surgery and cause discomfort, pressure symptoms, infection, or pain classified on VAS > 3.
- Failure of attempt with FNA
- Patients that refuse surgery
Key exclusion criteria (4 listed)
- pregnancy
- patients requiring urgent surgery
- Patient follow-up discontinued in our facility
- Symptomatic post-BCS early hematoma
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 |
|---|---|---|
| Hematoma Vaacum Assisted BiopsyAlso: Hematoma Core needle biopsyThe patient was placed supine and meticulous aseptic measures were applied. Prior procedure local anesthesia (lidocaine 1%) was administered following disinfection. A 5 mm skin incision is performed to guarantee appropriate access for the needle insertion in the hematomas. The evacuation was achieved using a Mammotome® vacuum-assisted system (Devicor Medical Products, Inc., Cincinnati, OH, USA), with an 8-G needle, under the guidance of the same high-resolution US equipment (MyLabTM 9 XP; Esaote SpA, Genoa) for preoperative assessment. Empty-needle function and the tissue-biopsy option is preferred to fragment the fibrotic tissue until the hematoma empties and its walls collapsed. Once VAEv is performed, the postoperative US is carried out and VAEv is repeated until more than 90% evacuations of hematoma volume if no complication occurs. | Device | Breast hematoma group |
Primary outcome
Hematoma vacuum assisted biopsy success rate I
Time frame: At the end of the procedure
Clearance of ≥70% postoperative hematoma
Symptom Resolution
Time frame: At the end of the procedure
Patient report visual analog scale (VAS) ≤3 (minimum 0; maximum 10) at the end of Hematoma vacuum assisted biopsy
Hematoma vacuum assisted biopsy success rate I
Time frame: 30 days from the procedure
Avoidance of surgery during follow-up for any reason
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 29 Dec 2022.
- Background: PubMed 32598321Almasarweh S, Sudah M, Joukainen S, Okuma H, Vanninen R, Masarwah A. The feasibility of ultrasound-guided vacuum-assisted evacuation of large breast hematomas. Radiol Oncol. 2020 Jun 26;54(3):311-316. doi: 10.2478/raon-2020-0041.
- Background: PubMed 31546843Guzman-Aroca F, Berna-Serna JD, Garcia-Ortega AA, Hernandez-Gomez D, Berna-Mestre JD. A New Management Technique for Symptomatic Haematomas Following Therapeutic Vacuum-Assisted Biopsy. J Clin Med. 2019 Sep 19;8(9):1493. doi: 10.3390/jcm8091493.
- Individual participant dataSharing planned: Undecided
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 Breast Haematoma and Breast Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
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 4 inclusion and 4 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 29 Dec 2022. 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 Italy. 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?
Hematoma vacuum assisted biopsy success rate I (time frame: At the end of the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665894, which also lists 2 linked publications.
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 29 Dec 2022.