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NCT03711916 · ClinicalTrials.gov registry record · NA
Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03711916: Completed NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03711916 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03711916, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- DEVICE PlasmaBlade 3.0S
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-03-17 |
| Est. Completion | 2018-12-03 |
| Phase | NA |
What the finished NCT03711916 record still lists
NCT03711916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which PlasmaBlade 3.0S is the first listed.
NCT03711916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03711916 about?
NCT03711916 is a clinical study titled "Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery". 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 devic...
What is the current status of trial NCT03711916?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-03-17. Estimated completion is 2018-12-03.
What interventions are being tested in trial NCT03711916?
The interventions under investigation include: PlasmaBlade 3.0S (DEVICE).
Who is sponsoring clinical trial NCT03711916?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03711916's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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