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NCT03711916
Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
NA trial testing PlasmaBlade 3.0S in Breast Cancer in 20 participants. Completed in 3 December 2018.
24 October 2018
Quick facts
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | device feasibility |
| Enrollment | 20 |
| Start date | 17 March 2017 |
| Primary completion | 24 October 2018 |
| Estimated completion | 3 December 2018 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- PlasmaBlade 3.0S
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Mastectomy — all drugs for Mastectomy →
- Perfusion; Complications — all drugs for Perfusion; Complications →
- Hemostasis — all drugs for Hemostasis →
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
Who can join
Adults 18 to 75, female only, with Breast Cancer or Mastectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparison of mastectomy and breast reconstruction outcomes using low thermal dissection versus traditional electrocautery: a blinded randomized trial.
Habibi M, Prasath V, Dembinski R, Sacks JM, et al · · 2021 · cited 4× · PMID 33742323 · DOI 10.1007/s10549-021-06177-9
Verify or expand the search:
- PubMed search for NCT03711916
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03711916 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Last refreshed: 18 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03711916.
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