Lokale Antibiotika für Brustimplantate (BREAST-AB)
Prophylaktische Behandlung von Brustimplantaten mit einer Lösung aus Gentamicin, Vancomycin und Cefazolin-Antibiotika für Frauen, die sich einer rekonstruktiven Brustoperation unterziehen: eine randomisierte kontrollierte Studie (The BREAST-AB Trial)
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The BREAST-AB Trial will include women undergoing breast reconstruction with implants. The objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. Participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. All patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. All patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. A total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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-
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Aalborg, Dänemark, 9000
- Aalborg University Hospital
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Aarhus, Dänemark, 8000
- Aarhus University Hospital
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Copenhagen, Dänemark, 2100
- Rigshospitalet
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Esbjerg, Dänemark, 6700
- South-West Jutland Hospital
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Herlev, Dänemark, 2730
- Herlev and Gentofte Hospital
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Odense, Dänemark, 5000
- Odense University Hospital
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Roskilde, Dänemark, 4000
- Zealand University Hospital
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Vejle, Dänemark, 7100
- Vejle Hospital
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
-
Age ≥ 18 years
-
Biologically female
-
Signed informed consent
-
Scheduled for breast reconstruction with implants or expanders including:
- Immediate or delayed reconstructions
- Bilateral or unilateral reconstructions
- With or without simultaneous flap reconstruction
Exclusion Criteria:
- Pregnancy
- Breast feeding
- Known allergy towards Vancomycin, Gentamicin and Cefazolin
- Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
- Known allergy towards neomycin
- Known impaired renal function with GFR < 60 mL/min
- Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
- Myasthenia Gravis
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Irrigation of implants with sterile isotonic saline
The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag. |
500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
Andere Namen:
|
|
Experimental: Irrigation of implants with a triple antibiotic solution
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline |
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
All-cause explantation of the breast implant after the breast reconstruction surgery
Zeitfenster: 180 days
|
All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation. |
180 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to explantation (days)
Zeitfenster: 180 days
|
Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery. |
180 days
|
|
Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)
Zeitfenster: 180 days
|
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment |
180 days
|
|
Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)
Zeitfenster: 180 days
|
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment |
180 days
|
|
Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery
Zeitfenster: 180 days
|
Surgical site infection will be defined according to the CDC classification of surgical site infetion leading to antibiotic treatment with oral or intravenous antibiotics administered after the surgery. |
180 days
|
|
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery
Zeitfenster: 1 year
|
All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation. |
1 year
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time from the breast reconstruction surgery to discharge (days)
Zeitfenster: 180 days
|
Time to discharge will be defined as the amount of days between the breast reconstruction and the day of discharge. |
180 days
|
|
Re-admission after the breast reconstruction surgery (Y/N)
Zeitfenster: 180 days
|
The breast reconstruction surgery will be defined as the surgery where the patient received the allocated treatment. |
180 days
|
|
Long term follow-up after 5, 10 and 15 years
Zeitfenster: 15 years
|
Capsular contracture and the Baker classification grade will be obtained from the National Patient Registry and the patients' medical journals after 5, 10 and 15 years. The BREAST-Q questionnaire will be used to assess patient-reported outcomes. The patients will be contacted and asked to fill out the questionnaire with 5 year-intervals after the surgery. |
15 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Mikkel Herly, MD, Ph.D., Department of Plastic Surgery and Burns Treatment
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Postoperative Komplikationen
- Pathologische Prozesse
- Entzündung
- Pathologische Zustände, Anzeichen und Symptome
- Fremdkörperreaktion
- Prothesenversagen
- Kapselkontraktur des Implantats
- Peptide
- Aminosäuren, Peptide und Proteine
- Schwefelverbindungen
- Organische Chemikalien
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Kohlenhydrate
- Glykoside
- Amides
- Aminoglykoside
- Glykoconjugate
- Beta-Lactams
- Lactams
- Cephalosporine
- Thiazinen
- Glycopeptide
- Vancomycin
- Cefazolin
- Gentamicine
Andere Studien-ID-Nummern
- BREAST-AB-01
- 2020-002459-40 (EudraCT-Nummer)
- 0058322 (Andere Zuschuss-/Finanzierungsnummer: Novo Nordisk Foundation)
- R-189- A4127 (Andere Zuschuss-/Finanzierungsnummer: Medicine Fund of the Danish Regions)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The protocol including the statistical analysis plan is published in BMJ Open (doi:10.1136/bmjopen-2021-058697) prior to unblinding. The main article will include the primary and secondary outcomes. The tertiary and long-term outcomes will be included in subsequent articles. The manuscripts will be submitted to peer-reviewed international journals and both positive, negative and inconclusive results will be published. The findings of the trial will be shared with participating sites and presented at national and international conferences. The results will be disseminated to the public but will not be shared directly with participating patients.
IPD-Sharing-Zeitrahmen
After the end of the trial, the data will become available (Anticipated july 2025)
IPD-Sharing-Zugriffskriterien
Researchers and other relevant parties can be granted access to selected anonymized data after publication upon request to the principal-sponsor investigator
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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