Lokale antibiotika til brystimplantater (BREAST-AB)
Profylaktisk behandling af brystimplantater med en opløsning af gentamicin, vancomycin og cefazolin antibiotika til kvinder, der gennemgår brystrekonstruktionskirurgi: et randomiseret kontrolleret forsøg (BREAST-AB-forsøget)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
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Aalborg, Danmark, 9000
- Aalborg University Hospital
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Aarhus, Danmark, 8000
- Aarhus University Hospital
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Copenhagen, Danmark, 2100
- Rigshospitalet
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Esbjerg, Danmark, 6700
- South-West Jutland Hospital
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Herlev, Danmark, 2730
- Herlev and Gentofte Hospital
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Odense, Danmark, 5000
- Odense University Hospital
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Roskilde, Danmark, 4000
- Zealand University Hospital
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Vejle, Danmark, 7100
- Vejle Hospital
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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:
-
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
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.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
All-cause explantation of the breast implant after the breast reconstruction surgery
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to explantation (days)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time from the breast reconstruction surgery to discharge (days)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mikkel Herly, MD, Ph.D., Department of Plastic Surgery and Burns Treatment
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Yderligere relevante MeSH-vilkår
- Postoperative komplikationer
- Patologiske processer
- Betændelse
- Patologiske tilstande, tegn og symptomer
- Fremmedlegemereaktion
- Protesesvigt
- Implantat kapselkontraktur
- Peptider
- Aminosyrer, peptider og proteiner
- Svovlforbindelser
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulhydrater
- Glycosider
- Amider
- Aminoglycosider
- Glycoconjugates
- beta-lactams
- Lactams
- Cephalosporiner
- Thiazines
- Glycopeptider
- Vancomycin
- Cefazolin
- Gentamiciner
Andre undersøgelses-id-numre
- BREAST-AB-01
- 2020-002459-40 (EudraCT nummer)
- 0058322 (Andet bevillings-/finansieringsnummer: Novo Nordisk Foundation)
- R-189- A4127 (Andet bevillings-/finansieringsnummer: Medicine Fund of the Danish Regions)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
After the end of the trial, the data will become available (Anticipated july 2025)
IPD-delingsadgangskriterier
Researchers and other relevant parties can be granted access to selected anonymized data after publication upon request to the principal-sponsor investigator
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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