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)
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
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). / Hemmingsen, Mathilde Nejrup; Larsen, Andreas; Weltz, Tim K.; Ørholt, Mathias; Wiberg, Sebastian; Bennedsen, Anne Karen; Bille, Camilla; Carstensen, Lena Felicia; Jensen, Lisa Toft; Bredgaard, Rikke; Koudahl, Vibeke; Schmidt, Volker Jürgen; Vester-Glowinski, Peter; Hölmich, Lisbet Rosenkrantz; Sørensen, Søren J.; Bjarnsholt, Thomas; Damsgaard, Tine; Herly, Mikkel.
In: BMJ Open, Vol. 12, No. 9, 2022, p. e058697.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery
T2 - protocol for a randomised, double-blind, placebo-controlled trial (The BREAST-AB trial)
AU - Hemmingsen, Mathilde Nejrup
AU - Larsen, Andreas
AU - Weltz, Tim K.
AU - Ørholt, Mathias
AU - Wiberg, Sebastian
AU - Bennedsen, Anne Karen
AU - Bille, Camilla
AU - Carstensen, Lena Felicia
AU - Jensen, Lisa Toft
AU - Bredgaard, Rikke
AU - Koudahl, Vibeke
AU - Schmidt, Volker Jürgen
AU - Vester-Glowinski, Peter
AU - Hölmich, Lisbet Rosenkrantz
AU - Sørensen, Søren J.
AU - Bjarnsholt, Thomas
AU - Damsgaard, Tine
AU - Herly, Mikkel
N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022
Y1 - 2022
N2 - INTRODUCTION: Periprosthetic infection is one of the most severe complications following implant-based breast reconstruction affecting 5%-10% of the women. Currently, many surgeons apply antibiotics locally on the breast implant to reduce the risk of postoperative infection, but no randomised, placebo-controlled trials have tested the treatment's efficacy. METHODS AND ANALYSIS: The BREAST-AB trial (BREAST-AntiBiotics) is an investigator-initiated, multicentre, randomised, placebo-controlled, double-blind trial of local treatment with gentamicin, vancomycin and cefazolin on breast implants in women undergoing implant-based breast reconstruction. The trial drug consists of 80 mg gentamicin, 1 g vancomycin and 1 g cefazolin dissolved in 500 mL of isotonic saline. The placebo solution consists of 500 mL isotonic saline. The trial drug is used to wash the dissected tissue pocket and the breast implant prior to insertion. The primary outcome is all-cause explantation of the breast implant within 180 days after the breast reconstruction surgery. This excludes cases where the implant is replaced with a new permanent implant, for example, for cosmetic reasons. Key long-term outcomes include capsular contracture and quality of life. The trial started on 26 January 2021 and is currently recruiting. ETHICS AND DISSEMINATION: The trial was approved by the Regional Ethics Committee of the Capital Region (H-20056592) on 1 January 2021 and the Danish Medicines Agency (2020070016) on 2 August 2020. The main paper will include the primary and secondary outcomes and will be submitted to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04731025.
AB - INTRODUCTION: Periprosthetic infection is one of the most severe complications following implant-based breast reconstruction affecting 5%-10% of the women. Currently, many surgeons apply antibiotics locally on the breast implant to reduce the risk of postoperative infection, but no randomised, placebo-controlled trials have tested the treatment's efficacy. METHODS AND ANALYSIS: The BREAST-AB trial (BREAST-AntiBiotics) is an investigator-initiated, multicentre, randomised, placebo-controlled, double-blind trial of local treatment with gentamicin, vancomycin and cefazolin on breast implants in women undergoing implant-based breast reconstruction. The trial drug consists of 80 mg gentamicin, 1 g vancomycin and 1 g cefazolin dissolved in 500 mL of isotonic saline. The placebo solution consists of 500 mL isotonic saline. The trial drug is used to wash the dissected tissue pocket and the breast implant prior to insertion. The primary outcome is all-cause explantation of the breast implant within 180 days after the breast reconstruction surgery. This excludes cases where the implant is replaced with a new permanent implant, for example, for cosmetic reasons. Key long-term outcomes include capsular contracture and quality of life. The trial started on 26 January 2021 and is currently recruiting. ETHICS AND DISSEMINATION: The trial was approved by the Regional Ethics Committee of the Capital Region (H-20056592) on 1 January 2021 and the Danish Medicines Agency (2020070016) on 2 August 2020. The main paper will include the primary and secondary outcomes and will be submitted to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04731025.
KW - breast surgery
KW - clinical trials
KW - plastic & reconstructive surgery
U2 - 10.1136/bmjopen-2021-058697
DO - 10.1136/bmjopen-2021-058697
M3 - Journal article
C2 - 36115667
AN - SCOPUS:85138137674
VL - 12
SP - e058697
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 9
ER -
ID: 321288999