Local Antibiotics for Women Undergoing Breast Reconstruction Surgery with Implants

2024-517672-38-00 Protocol BREAST-AB-01 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 20 Sep 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 6 sites · Protocol BREAST-AB-01

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 1,003
Countries 1
Sites 6

Infection

The BREAST-AB trial is designed to assess the effect of locally applied antibiotics on all-cause loss of the implant after implant-based breast reconstruction. We hypothesise that local application of gentamicin, vancomycin and cefazolin decrease the risk of postoperative clinical infections and thereby reduce the risk…

Key facts

Sponsor
Rigshospitalet
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Female
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01]
Trial duration
20 Sep 2024 → ongoing
Decision date (initial)
2024-09-20
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-517672-38-00
EudraCT number
2020-002459-40
ClinicalTrials.gov
NCT04731025

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

The BREAST-AB trial is designed to assess the effect of locally applied antibiotics on all-cause loss of the implant after implant-based breast reconstruction. We hypothesise that local application of gentamicin, vancomycin and cefazolin decrease the risk of postoperative clinical infections and thereby reduce the risk of losing the implant to the benefit of women undergoing implant-based breast reconstruction.

Conditions and MedDRA coding

Infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Age ≥ 18 years
  2. Biologically female
  3. Signed informed consent
  4. Scheduled for breast reconstruction with implants or expanders including: a. Immediate or delayed reconstructions b. Bilateral or unilateral reconstructions c. With or without simultaneous flap reconstruction

Exclusion criteria 8

  1. Pregnancy
  2. Breast feeding
  3. Known allergy towards Vancomycin, Gentamicin and Cefazolin
  4. Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
  5. Known allergy towards neomycin
  6. Known impaired renal function with GFR < 60 mL/min
  7. Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
  8. Myasthenia Gravis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery

Secondary endpoints 6

  1. Time to explantation (days)
  2. All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery (Y/N)
  3. Revision surgery with incision of the fibrous capsule within 180 days after the breast reconstruction surgery (Y/N)
  4. Exchange of permanent implant to expander implant within 180 days after the breast reconstruction surgery (Y/N)
  5. Surgical site infection that leads to antibiotic treatment within 180 days after the breast reconstruction surgery (Y/N)
  6. Infection-specific revision surgery: Revision surgery due to clinically suspected deep surgical site infection with surgical access to the breast implant pocket or clinical signs of an infection in the breast implant pocket found intraoperatively within 180 days after the breast reconstruction surgery (Y/N)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Gentamicin

SUB02326MIG · Substance

Active substance
Gentamicin
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
TOPICAL
Max daily dose
80 mg milligram(s)
Max total dose
80 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vancomycin

SCP121117533 · ATC

Active substance
Vancomycin
Substance synonyms
VANCOMYCINUM
Route of administration
TOPICAL
Max daily dose
1 g gram(s)
Max total dose
1 g gram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J01XA01 — VANCOMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefazolin Sodium

SCP107201252 · ATC

Active substance
Cefazolin Sodium
Route of administration
TOPICAL
Max daily dose
1 g gram(s)
Max total dose
1 g gram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J01DB04 — CEFAZOLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefazolin Hikma 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung

PRD6483465 · Product

Active substance
Cefazolin Sodium
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
TOPICAL
Max daily dose
1 g gram(s)
Max total dose
1 g gram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J01DB04 — -
Marketing authorisation
6127999.02.00
MA holder
HIKMA FARMACÊUTICA (PORTUGAL), S.A.
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 2

Sodium Chloride

SUB12581MIG · Substance

Active substance
Sodium Chloride
Pharmaceutical form
INFUSION
Route of administration
TOPICAL
Max daily dose
1000 ml millilitre(s)
Max total dose
1000 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Natriumklorid Fresenius Kabi 9 mg/ml infusionsvätska, lösning

PRD10351326 · Product

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
TOPICAL USE
Max daily dose
500 ml millilitre(s)
Max total dose
500 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
B05BB01 — ELECTROLYTES
Marketing authorisation
7992
MA holder
FRESENIUS KABI AB
MA country
Finland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

94 Total trials 54 Recruiting 24 Ended
Academic / Non-commercial
Sponsor organisation
Rigshospitalet
Address
Blegdamsvej 9
City
Copenhagen Oe
Postcode
2100
Country
Denmark

Scientific contact point

Organisation
Rigshospitalet
Contact name
Mikkel Herly

Public contact point

Organisation
Rigshospitalet
Contact name
Mikkel Herly

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 6 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 1,003 6
Rest of world — 0 —

Investigational sites

Denmark

6 sites · Ongoing, recruiting
Aarhus Universitetshospital
Plastic Surgery, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Herlev Hospital
Plastic Surgery, Borgmester Ib Juuls Vej 1, 2730, Herlev
Rigshospitalet
Plastic Surgery and Burns Treatment, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Plastic Surgery, J B Winsloews Vej 4, 5000, Odense C
Aalborg University Hospital
Plastic Surgery, Moelleparkvej 4, 9000, Aalborg
Roskilde Hospital
Plastic Surgery, Sygehusvej 10, 4000, Roskilde

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2024-09-20 2024-09-20

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocol 3.0
Protocol (for publication) Protocol_EU_CT_number_2024-517672-38-00 3.0
Recruitment arrangements (for publication) Placeholder document recruitment arrangements etc 1
Subject information and informed consent form (for publication) informed consent form and subject information 2.3
Summary of Product Characteristics (SmPC) (for publication) Bactocin pulver til infusionsvske oplsning 500 mg og 1000 mg 1
Summary of Product Characteristics (SmPC) (for publication) Cefazolin Hikma 2 g 875778 DE 1
Summary of Product Characteristics (SmPC) (for publication) Cefazolin MIP pulver til injektions- og infusionsvske oplsning 2 g 1
Summary of Product Characteristics (SmPC) (for publication) Hexamycin injektionsvske oplsning 40 mg_ml 1
Synopsis of the protocol (for publication) Protocol_synopsis_ENG_EU_CT_number_2024-517672-38-00 1.1
Synopsis of the protocol (for publication) Trial_synopsis 1.1

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-30 Denmark Acceptable
2024-09-19
 2024-09-20
2 SUBSTANTIAL MODIFICATION SM-1 2024-10-10 Denmark Acceptable
2024-10-23
 2024-11-26
3 SUBSTANTIAL MODIFICATION SM-2 2025-10-15 Denmark Acceptable
2025-10-17
 2025-10-17
4 SUBSTANTIAL MODIFICATION SM-3 2025-10-27 Denmark Acceptable
2025-10-28
 2025-10-28
5 SUBSTANTIAL MODIFICATION SM-4 2026-01-06 Denmark Acceptable
2026-01-29
 2026-02-05

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