Antibiotiques locaux pour implants mammaires (BREAST-AB)
Traitement prophylactique des implants mammaires avec une solution d'antibiotiques à base de gentamicine, de vancomycine et de céfazoline pour les femmes subissant une chirurgie reconstructive mammaire : un essai contrôlé randomisé (l'essai BREAST-AB)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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-
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Aalborg, Danemark, 9000
- Aalborg University Hospital
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Aarhus, Danemark, 8000
- Aarhus University Hospital
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Copenhagen, Danemark, 2100
- Rigshospitalet
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Esbjerg, Danemark, 6700
- South-West Jutland Hospital
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Herlev, Danemark, 2730
- Herlev and Gentofte Hospital
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Odense, Danemark, 5000
- Odense University Hospital
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Roskilde, Danemark, 4000
- Zealand University Hospital
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Vejle, Danemark, 7100
- Vejle Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: 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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
All-cause explantation of the breast implant after the breast reconstruction surgery
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to explantation (days)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time from the breast reconstruction surgery to discharge (days)
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mikkel Herly, MD, Ph.D., Department of Plastic Surgery and Burns Treatment
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Complications postopératoires
- Processus pathologiques
- Inflammation
- Conditions pathologiques, signes et symptômes
- Réaction à un corps étranger
- Échec de la prothèse
- Contracture capsulaire implantaire
- Peptides
- Acides aminés, peptides et protéines
- Composés de soufre
- Produits chimiques organiques
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Glucides
- Glycosides
- Amides
- Aminoglycosides
- Glycoconjuguis
- bêta-lactams
- Lactame
- Céphalosporines
- Thiazines
- Glycopeptides
- Vancomycine
- Céfazoline
- Gentamicines
Autres numéros d'identification d'étude
- BREAST-AB-01
- 2020-002459-40 (Numéro EudraCT)
- 0058322 (Autre subvention/numéro de financement: Novo Nordisk Foundation)
- R-189- A4127 (Autre subvention/numéro de financement: Medicine Fund of the Danish Regions)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
After the end of the trial, the data will become available (Anticipated july 2025)
Critères d'accès au partage IPD
Researchers and other relevant parties can be granted access to selected anonymized data after publication upon request to the principal-sponsor investigator
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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