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Local Antibiotics for Breast Implants (BREAST-AB)

Primary Purpose

Implant Complication, Implant Infection, Implant Site Infection

Status
Recruiting
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Gentamicin, Cefazolin and Vancomycin
Placebo
Sponsored by
Mikkel Herly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Implant Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Biologically female
  • Signed informed consent
  • Scheduled for breast reconstruction with implants or expanders including:

    1. Immediate or delayed reconstructions
    2. Bilateral or unilateral reconstructions
    3. 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

Sites / Locations

  • Aalborg University HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • RigshospitaletRecruiting
  • South-West Jutland Hospital
  • Herlev and Gentofte HospitalRecruiting
  • Odense University HospitalRecruiting
  • Zealand University HospitalRecruiting
  • Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Irrigation of implants with sterile isotonic saline

Irrigation of implants with a triple antibiotic solution

Arm Description

The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.

The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline

Outcomes

Primary Outcome Measures

All-cause explantation of the breast implant after the breast reconstruction surgery
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.

Secondary Outcome Measures

Time to explantation (days)
Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery.
Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment
Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment
Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery
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.
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery
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.

Full Information

First Posted
January 26, 2021
Last Updated
February 7, 2023
Sponsor
Mikkel Herly
Collaborators
University of Copenhagen, Herlev and Gentofte Hospital, Zealand University Hospital, Odense University Hospital, Vejle Hospital, Hospital of South West Jutland, Aarhus University Hospital, Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04731025
Brief Title
Local Antibiotics for Breast Implants
Acronym
BREAST-AB
Official Title
Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
July 27, 2025 (Anticipated)
Study Completion Date
January 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mikkel Herly
Collaborators
University of Copenhagen, Herlev and Gentofte Hospital, Zealand University Hospital, Odense University Hospital, Vejle Hospital, Hospital of South West Jutland, Aarhus University Hospital, Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion, Antibiotic Side Effect

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The trial will be double-blind so that the patients, site investigators and data monitors will be blinded to the allocation. Only the designated nurses and the members of the trial coordinating unit (who provide the randomization number and treatment allocation) are not blinded to the allocation. The unblinded persons will not in any way be part of the treatment, clinical evaluation of outcomes or data assessment.
Allocation
Randomized
Enrollment
1003 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Irrigation of implants with sterile isotonic saline
Arm Type
Placebo Comparator
Arm Description
The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.
Arm Title
Irrigation of implants with a triple antibiotic solution
Arm Type
Experimental
Arm Description
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline
Intervention Type
Drug
Intervention Name(s)
Gentamicin, Cefazolin and Vancomycin
Other Intervention Name(s)
Hexamycin, Cefazolin "MIP" and Bactocin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Natriumklorid Fresenius Kabi 9 mg-ml
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause explantation of the breast implant after the breast reconstruction surgery
Description
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.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Time to explantation (days)
Description
Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery.
Time Frame
180 days
Title
Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)
Description
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment
Time Frame
180 days
Title
Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)
Description
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment
Time Frame
180 days
Title
Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery
Description
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.
Time Frame
180 days
Title
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Time from the breast reconstruction surgery to discharge (days)
Description
Time to discharge will be defined as the amount of days between the breast reconstruction and the day of discharge.
Time Frame
180 days
Title
Re-admission after the breast reconstruction surgery (Y/N)
Description
The breast reconstruction surgery will be defined as the surgery where the patient received the allocated treatment.
Time Frame
180 days
Title
Long term follow-up after 5, 10 and 15 years
Description
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.
Time Frame
15 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikkel Herly, MD, Ph.D.
Phone
+45 27598919
Email
mikkel.herly@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde Hemmingsen, MD
Phone
+45 28568205
Email
mathilde.nejrup.hemmingsen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel Herly, MD, Ph.D.
Organizational Affiliation
Department of Plastic Surgery and Burns Treatment
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lene Birk-Sørensen, MD
Phone
+45 97660624
Email
l.birksoerensen@rn.dk
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikkel Rindom, MD
Phone
+45 24 60 93 21
Email
MIKKOC@rm.dk
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikkel Herly, MD, Phd
Phone
+45 27598919
Email
mikkel.herly@regionh.dk
First Name & Middle Initial & Last Name & Degree
Mathilde N Hemmingsen, MD
Phone
+45 28568205
Email
mathilde.nejrup.hemmingsen@regionh.dk
Facility Name
South-West Jutland Hospital
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena F Carstensen, MD
Phone
+45 20 15 20 19
Email
Lena.Felicia.Carstensen@rsyd.dk
Facility Name
Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisbet R Hölmich, MD, DMSc
Phone
+45 27 20 00 14
Email
lisbet.rosenkrantz.hoelmich@regionh.dk
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Bille, Phd
Phone
+45 65 41 24 45
Email
Camilla.Bille@rsyd.dk
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Rose, MD
Email
mrose@regionsjaelland.dk
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bekka Christensen, MD
Email
Bekka.Anina.Ozer.Christensen@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 Time Frame
After the end of the trial, the data will become available (Anticipated july 2025)
IPD Sharing Access Criteria
Researchers and other relevant parties can be granted access to selected anonymized data after publication upon request to the principal-sponsor investigator
Citations:
PubMed Identifier
36115667
Citation
Hemmingsen MN, Larsen A, Weltz TK, Orholt M, Wiberg S, Bennedsen AK, Bille C, Carstensen LF, Jensen LT, Bredgaard R, Koudahl V, Schmidt VJ, Vester-Glowinski P, Holmich LR, Sorensen SJ, Bjarnsholt T, Damsgaard T, Herly M. Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: protocol for a randomised, double-blind, placebo-controlled trial (The BREAST-AB trial). BMJ Open. 2022 Sep 17;12(9):e058697. doi: 10.1136/bmjopen-2021-058697.
Results Reference
derived
Links:
URL
https://bmjopen.bmj.com/content/12/9/e058697.abstract
Description
Study protocol published in BMJ Open

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Local Antibiotics for Breast Implants

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