- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03711916
Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
Pilot Study: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21224
- Bayview Medical Center
-
Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Hospital Outpatient Center
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Enhedens gennemførlighed
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Breast flap creation with PlasmaBlade
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.
|
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.
|
Ingen indgriben: Breast flap creation with Bovie Cautery
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Perfusion
Tidsramme: 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.
|
Day of Surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Drainage
Tidsramme: Up to 14 days post-operatively.
|
Patient records amount of drainage (in cc's) from each drain until drain is removed by plastic surgeon.
|
Up to 14 days post-operatively.
|
Pain Scores
Tidsramme: Days 1,2,3,7,30 Post-operatively
|
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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mehran Habibi, MD, Johns Hopkins Medicine Department of Surgery
- Ledende efterforsker: Gedge D Rosson, MD, Johns Hopkins Medicine Department of Plastic, Reconstructive & Maxillofacial Surgery
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- J1697
- IRB00108493 (Anden identifikator: JHM IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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