- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21224
- Bayview Medical Center
-
Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins Hospital Outpatient Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Perfusion
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Drainage
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Mehran Habibi, MD, Johns Hopkins Medicine Department of Surgery
- Huvudutredare: Gedge D Rosson, MD, Johns Hopkins Medicine Department of Plastic, Reconstructive & Maxillofacial Surgery
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- J1697
- IRB00108493 (Annan identifierare: JHM IRB)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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