Implant-based breast reconstruction following mastectomy
Conditions
Interventions
Trade Name: Cefazolin
Product Name: Cefazolin
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: CEFAZOLIN
CAS Number: 25953-19-9
Concentration unit: mg m
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients must fulfill all the following criteria to be eligible for inclusion in the trial: - Age = 18 years - Biologically female - Signed informed consent - Scheduled for breast reconstruction with implants including immediate/delayed reconstructions and bilateral/unilateral reconstructions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 703 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: Patients are considered ineligible if any of the following criteria is fulfilled: - 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 < 6 mL/min - Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity - Myasthenia Gravis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Administration of antibiotics directly on to the breast implant and dissected implant pocket will give a high concentration of the antibiotics where they are needed which may prevent bacterial contamination of the implant. This may decrease the rate of postoperative infections that lead to explantation of the implant and thereby improve the outcome for the patients. ;Secondary Objective: Not applicable;Primary end point(s): All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery Definition: 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, Rationale: The rationale for applying local antibiotics is to decrease the risk of severe complications associated with the presence of bacteria such as deep surgical site infection that leads to explantation and discarding of the implant. Postoperative infection that leads to explantation of the implant will sometimes occur simultaneously with other complications where the cause of explantation may be unclear. Therefore, all-cause explantation is a logical and meaningful primary outcome. The reason for excluding from the primary outcome: explantations of permanent implants followed by replacements with a new permanent implant for cosmetic reasons, is that such revisional surgery is not considered a proxy for severe complications that may be associated with a deep surgical site infection. ;Timepoint(s) of evaluation of this end point: The endpoint will be evaluated within the first 180 days after the surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes will include: - Time to explantation (days) - All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery (Y/N) - Revision surgery with incision of the fibrous capsule within 180 days after the breast reconstruction surgery (Y/N) - Exchange of permanent implant to expander implant within 180 days after the breast reconstruction surgery (Y/N) - Surgical site infection that leads to antibiotic treatment within 180 days after the breast reconstruction surgery (Y/N) Definition: Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery. The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment. 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. The tertiary outcomes will be assessed for patients undergoing unilateral breast reconstruction. The tertiary outcomes will include: - Time from the breast reconstruction surgery to discharge (days) - Re-admission within 180 days after the breast reconstruction surgery (Y/N) Definition: Time to discharge will be defined as the amount of days between the breast reconstruction and the day of discharge. The breast reconstruction surgery will be defined as the surgery where the patient received the allocated treatment. The trial will include additional long-term outcomes focused on all-cause incision of the fibrous capsule around the breast implant, capsular contracture, Baker classification and quality-of-life. ;Timepoint(s) of evaluation of this end point: Secondary and tertiary endpoints will be evaluated 180 days after the surgery. The additional long term follow-up will be evaluated 5, 10 and 15 years after the trial termination (last patient last visit) | — |
Countries
Denmark
Contacts
Public ContactThe Trial Coordinating Unit
Rigshospitalet
Outcome results
None listed