Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/7/2019 |
| Start Date: | August 2016 |
| End Date: | July 2019 |
| Contact: | Mehran Habibi, MD |
| Email: | mhabibi2@jhmi.edu |
| Phone: | 410-550-5522 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Active connective tissue disease.
- History of, or plan to undergo irradiation of the breasts.
We found this trial at
2
sites
Baltimore, Maryland 21287
Principal Investigator: Mehran Habibi, MD
Phone: 410-955-9477
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