Breast CancerNCT03711916
Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
A study testing PlasmaBlade 3.0S in people with Breast Cancer and Mastectomy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection device. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Mastectomy, Perfusion; Complications
- What is being tested?
- PlasmaBlade 3.0S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2017to 3 Dec 2018
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-75 years.
- Choose bilateral mastectomy followed by immediate breast reconstruction.
- Have no inflammatory breast cancers.
- Have not had radiotherapy before mastectomy.
- Understand the study purpose, requirements, and risks.
- Be able and willing to give informed consent.
Who cannot join
- Active connective tissue disease.
- History of, or plan to undergo irradiation of the breasts.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins Hospital Outpatient Center
Baltimore, Maryland, 21287
About this study
Official title: Pilot Study: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction
Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection device. Thus, low thermal devices would improve flap perfusion by decreasing the thermal injury resulted by the dissection. Looking into the use of low thermal devices in cases of mastectomy and immediate breast reconstruction has not been documented. The aim of this study is to determine if there are clinical flap perfusion, surgical site drainage, and pain scores differences between mastectomy flaps created using low thermal dissection device and those done with the standard care of Bovie cautery in order to warrant a formal study.
Read the detailed description
This is a single-blinded, randomized, controlled clinical trial comparing postoperative flap perfusion and surgical site drainage between patients randomized to breast flap creation by PlasmaBlade (low thermal dissection intervention) on one breast and by a Bovie cautery (Control) for the contralateral breast flap. Candidates will have elected to undergo bilateral post-mastectomy immediate breast reconstruction (IBR). Participants meeting inclusion criteria will be enrolled and baseline data collection completed prior to randomization and surgery.
Patients and the plastic surgeon will be blinded in regards to intervention randomization. Only the oncology surgeon has knowledge of which device used for each breast flap. However, after the plastic surgeon makes the assessment of the flap, he/she will be unblinded in order to complete the reconstruction procedure using the same dissection device on the same side it was used for in the mastectomy procedure. Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-operative flap perfusion will be recorded using SPY imaging system. Surgical site drainage will be measured until drainage removal. Post-operative pain (Visual Analog Scale for Pain) and the occurrence of adverse events will be recorded up until discharge and 30-days postoperative follow up visit.
- Conditions
- Breast Cancer, Mastectomy, Perfusion; Complications, Hemostasis
- Being tested
- PlasmaBlade 3.0S
- Keywords
- Breast cancer, Mastectomy, Perfusion, Hemostasis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaBlade 3.0SDevice
PlasmaBlade (Medtronic) is approved by United States Food and Drug Administration (FDA) as a low thermal dissection device that has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection devices.
| Study group | Role | What they receive |
|---|---|---|
| Breast flap creation with PlasmaBlade | Experimental | During participant's scheduled bilateral mastectomy, breast flap on one breast will be created using low thermal dissection device (PlasmaBlade) on one breast and standard Bovie cautery in the contralateral breast. Receives: Device: PlasmaBlade 3.0S |
| Breast flap creation with Bovie Cautery | No intervention | During participant's scheduled bilateral mastectomy, breast flap will be created using standard Bovie cautery on the breast contralateral to the one that was created using PlasmaBlade. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion
Plastic surgeon objectively assesses degree of perfusion with the SPY Perfusion Assessment system (intra-operative fluorescence imaging system). Plastic surgeon describes perfusion as Left better than Right, Right better than Left, or both sides equally perfused.
Measured: Day of Surgery
Secondary outcomes (2)
Drainage
Patient records amount of drainage (in cc's) from each drain until drain is removed by plastic surgeon.
Measured: Up to 14 days post-operatively.
Pain Scores
Patient records pains scores using Visual Analog Scale (10cm long line upon which patients indicates level of pain)for each side at Day 1, 2, 3, 7, and 30. Scores range from 0-10. Score of 0 corresponds with 0 cm on the line and 10 corresponds with 10cm on the line. 0 indicates no pain and 10 indicates most severe pain.
Measured: Days 1,2,3,7,30 Post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start17 Mar 2017
- Primary completion24 Oct 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Mehran Habibi, MD, Principal investigator, Johns Hopkins Medicine Department of SurgeryGedge D Rosson, MD, Principal investigator, Johns Hopkins Medicine Department of Plastic, Reconstructive & Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711916
- Sponsor's protocol ID
- J1697
- Other IDs
- IRB00108493
- Status last verified
- Jun 2019
- First submitted
- 17 Oct 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Habibi M, Prasath V, Dembinski R, Sacks JM, Rosson GD, Sebai ME, Mirkhaef S, Bello RJ, Siotos C, Broderick KP. Comparison of mastectomy and breast reconstruction outcomes using low thermal dissection versus traditional electrocautery: a blinded randomized trial. Breast Cancer Res Treat. 2021 Jul;188(1):101-106. doi: 10.1007/s10549-021-06177-9. Epub 2021 Mar 19.
PubMed 33742323
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03711916
- Acronym / sponsor ID
- J1697
- Conditions
- Breast Cancer, Mastectomy, Perfusion; Complications, Hemostasis
- Keywords
- Breast cancer, Mastectomy, Perfusion, Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 19 Oct 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.
Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection device. Thus, low thermal devices would improve flap perfusion by decreasing the thermal injury resulted by the dissection. Looking into the use of low thermal devices in cases of mastectomy and immediate breast reconstruction has not been documented. The aim of this study is to determine if there are clinical flap perfusion, surgical site drainage, and pain scores differences between mastectomy flaps created using low thermal dissection device and those done with the standard care of Bovie cautery in order to warrant a formal study.
Detailed description
This is a single-blinded, randomized, controlled clinical trial comparing postoperative flap perfusion and surgical site drainage between patients randomized to breast flap creation by PlasmaBlade (low thermal dissection intervention) on one breast and by a Bovie cautery (Control) for the contralateral breast flap. Candidates will have elected to undergo bilateral post-mastectomy immediate breast reconstruction (IBR). Participants meeting inclusion criteria will be enrolled and baseline data collection completed prior to randomization and surgery.
Patients and the plastic surgeon will be blinded in regards to intervention randomization. Only the oncology surgeon has knowledge of which device used for each breast flap. However, after the plastic surgeon makes the assessment of the flap, he/she will be unblinded in order to complete the reconstruction procedure using the same dissection device on the same side it was used for in the mastectomy procedure. Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-operative flap perfusion will be recorded using SPY imaging system. Surgical site drainage will be measured until drainage removal. Post-operative pain (Visual Analog Scale for Pain) and the occurrence of adverse events will be recorded up until discharge and 30-days postoperative follow up visit.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast flap creation with PlasmaBlade | Experimental | Device: PlasmaBlade 3.0SDuring participant's scheduled bilateral mastectomy, breast flap on one breast will be created using low thermal dissection device (PlasmaBlade) on one breast and standard Bovie cautery in the contralateral breast. |
| Breast flap creation with Bovie Cautery | No intervention | –During participant's scheduled bilateral mastectomy, breast flap will be created using standard Bovie cautery on the breast contralateral to the one that was created using PlasmaBlade. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 18-75 years.
- Choose bilateral mastectomy followed by immediate breast reconstruction.
- Have no inflammatory breast cancers.
- Have not had radiotherapy before mastectomy.
- Understand the study purpose, requirements, and risks.
Key exclusion criteria (2 listed)
- Active connective tissue disease.
- History of, or plan to undergo irradiation of the breasts.
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 |
|---|---|---|
| PlasmaBlade 3.0SPlasmaBlade (Medtronic) is approved by United States Food and Drug Administration (FDA) as a low thermal dissection device that has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection devices. | Device | Breast flap creation with PlasmaBlade |
Primary outcome
Perfusion
Time frame: Day of Surgery
Plastic surgeon objectively assesses degree of perfusion with the SPY Perfusion Assessment system (intra-operative fluorescence imaging system). Plastic surgeon describes perfusion as Left better than Right, Right better than Left, or both sides equally perfused.
2 secondary outcomes
Drainage
Time frame: Up to 14 days post-operatively.
Pain Scores
Time frame: Days 1,2,3,7,30 Post-operatively
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 18 Jun 2019.
- Derived from this study: PubMed 33742323Habibi M, Prasath V, Dembinski R, Sacks JM, Rosson GD, Sebai ME, Mirkhaef S, Bello RJ, Siotos C, Broderick KP. Comparison of mastectomy and breast reconstruction outcomes using low thermal dissection versus traditional electrocautery: a blinded randomized trial. Breast Cancer Res Treat. 2021 Jul;188(1):101-106. doi: 10.1007/s10549-021-06177-9. Epub 2021 Mar 19.
- 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.
Mehran Habibi, MD principal investigator
Johns Hopkins Medicine Department of Surgery
Gedge D Rosson, MD principal investigator
Johns Hopkins Medicine Department of Plastic, Reconstructive & Maxillofacial Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlasmaBlade 3.0S in people with Breast Cancer and Mastectomy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
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 6 inclusion and 2 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 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Perfusion (time frame: Day of Surgery). 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 NCT03711916, which also lists 1 linked publication.
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 18 Jun 2019.