Breast Cancer Clinical Trial
Official title:
Pilot Study: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction
Verified date | June 2019 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 3, 2018 |
Est. primary completion date | October 24, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Bayview Medical Center | Baltimore | Maryland |
United States | Johns Hopkins Hospital Outpatient Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Medtronic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day of Surgery | |
Secondary | Drainage | Patient records amount of drainage (in cc's) from each drain until drain is removed by plastic surgeon. | Up to 14 days post-operatively. | |
Secondary | 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. | Days 1,2,3,7,30 Post-operatively |
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