Implant ComplicationPhase 3BREAST-ABNCT04731025
Local Antibiotics for Breast Implants
A Phase 3 study testing Gentamicin, Cefazolin and Vancomycin in people with Implant Complication and Implant Infection, run by Mikkel Herly at 8 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Implant Complication, Implant Infection, Implant Site Infection
- What is being tested?
- Gentamicin, Cefazolin and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,003 participants
- Where
- 8 sitesDenmark
- Study dates
- 27 Jan 2021to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8000
Rigshospitalet
Copenhagen, 2100
South-West Jutland Hospital
Esbjerg, 6700
Herlev and Gentofte Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
Zealand University Hospital
Roskilde, 4000
Vejle Hospital
Vejle, 7100
About this study
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)
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.
Read the 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.
- Conditions
- Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion
- Being tested
- Gentamicin, Cefazolin and Vancomycin, Placebo
- Medical subject headings
- Implant Capsular Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamicin, Cefazolin and VancomycinDrug
Also called Hexamycin, Cefazolin "MIP" and Bactocin
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.
PlaceboOther
Also called Natriumklorid Fresenius Kabi 9 mg-ml
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.
| Study group | Role | What they receive |
|---|---|---|
| Irrigation of implants with sterile isotonic saline | Placebo comparator | The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag. Receives: Other: Placebo |
| Irrigation of implants with a triple antibiotic solution | Experimental | The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline Receives: Drug: Gentamicin, Cefazolin and Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (5)
Time to explantation (days)
Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery.
Measured: 180 days
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
Measured: 180 days
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
Measured: 180 days
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.
Measured: 180 days
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start27 Jan 2021
- Primary completion26 Sep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,003 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mikkel Herly
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Herlev and Gentofte Hospital, Zealand University Hospital, Odense University Hospital, Vejle Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Aarhus University Hospital, Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Mikkel Herly, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mikkel Herly, MD, Ph.D., Principal investigator, Department of Plastic Surgery and Burns Treatment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731025
- Sponsor's protocol ID
- BREAST-AB-01
- Other IDs
- 2020-002459-40, 0058322, R-189- A4127
- Acronym
- BREAST-AB
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36115667
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04731025
- Acronym / sponsor ID
- BREAST-AB / BREAST-AB-01
- Conditions
- Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,003 participants (estimated)
- Lead sponsor
- Mikkel HerlyUniversity, hospital or other
- Collaborators
- University of Copenhagen, Herlev and Gentofte Hospital, Zealand University Hospital, Odense University Hospital, Vejle Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Aarhus University Hospital, Aalborg University Hospital
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation of implants with sterile isotonic saline | Placebo comparator | Other: PlaceboThe placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag. |
| Irrigation of implants with a triple antibiotic solution | Experimental | Drug: Gentamicin, Cefazolin and VancomycinThe antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Biologically female
- Signed informed consent
- Scheduled for breast reconstruction with implants or expanders including:
Key exclusion criteria (8 listed)
- Pregnancy
- Breast feeding
- Known allergy towards Vancomycin, Gentamicin and Cefazolin
- Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
- Known allergy towards neomycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentamicin, Cefazolin and VancomycinAlso: Hexamycin, Cefazolin "MIP" and BactocinThe 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. | Drug | Irrigation of implants with a triple antibiotic solution |
| PlaceboAlso: Natriumklorid Fresenius Kabi 9 mg-ml500 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. | Other | Irrigation of implants with sterile isotonic saline |
Primary outcome
All-cause explantation of the breast implant after the breast reconstruction surgery
Time frame: 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.
5 secondary outcomes
Time to explantation (days)
Time frame: 180 days
Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)
Time frame: 180 days
Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)
Time frame: 180 days
Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery
Time frame: 180 days
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Derived from this study: PubMed 36115667Hemmingsen 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.
- Study protocol published in BMJ OpenLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel Herly, MD, Ph.D. principal investigator
Department of Plastic Surgery and Burns Treatment
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gentamicin, Cefazolin and Vancomycin in people with Implant Complication and Implant Infection, run by Mikkel Herly at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause explantation of the breast implant after the breast reconstruction surgery (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.