A study on antibiotic prophylaxis in patients with breast cancer or a history of breast cancer, undergoing breast reconstruction with implants.

Antibiotic prophylaxis in patients undergoing primary or secondary breast reconstruction with implants, a randomized parallel two armed prospective clinical trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004878-26-SE

Enrollment

870

Registered

2012-11-09

Start date

2013-02-07

Completion date

Unknown

Last updated

2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The incidence of postoperative infections in patients with breast cancer or a history of breast cancer, after elective surgery with primary or secondary first-time breast reconstruction with implants, given single dose or multiple doses of antibiotic prophylaxis.

Interventions

Trade Name: Kloxacillin 2g OR Klindamycin 600 mg Product Name: Kloxacillin or Klindamycin Product Code: 23584 or 25998 Pharmaceutical Form: Infusion INN or Proposed INN: CLOXACILLIN CAS Number: 61-72-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women >18 years old Present diagnosis or a history of breast cancer Elective surgery with primary or secondary first-time breast reconstruction with implants. 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 780 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: Unable to understand Swedish language Allergy to any of the study drugs (Kloxacillin/Klindamycin)

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate which intravenous antibiotic prophylaxis, single dose or multiple doses, that is the most effective concerning postoperative infections after primary and secondary first-time breast reconstruction with implants.;Secondary Objective: Investigate if there is any difference in the incidence of adverse drug reactions between the single-dose and the multiple-dose antibiotic regimen;Primary end point(s): Postoperative infection: Infection that leads to re-surgery with removal of the breast implant;Timepoint(s) of evaluation of this end point: Follow-up on patients will be done at the following points in time: 10 days (+-3 days) after surgery 1 months (+- 7 days) after surgery 3 months (+- 7 days) after surgery 6 months (+- 14 days) after surgery 12 months (+- 14 days) after surgery	—

Measure

Time frame

Main Objective: Investigate which intravenous antibiotic prophylaxis, single dose or multiple doses, that is the most effective concerning postoperative infections after primary and secondary first-time breast reconstruction with implants.;Secondary Objective: Investigate if there is any difference in the incidence of adverse drug reactions between the single-dose and the multiple-dose antibiotic regimen;Primary end point(s): Postoperative infection: Infection that leads to re-surgery with removal of the breast implant;Timepoint(s) of evaluation of this end point: Follow-up on patients will be done at the following points in time: 10 days (+-3 days) after surgery 1 months (+- 7 days) after surgery 3 months (+- 7 days) after surgery 6 months (+- 14 days) after surgery 12 months (+- 14 days) after surgery

—

Secondary

Measure	Time frame
Secondary end point(s): Infection that requires per oral/parenteral antibiotics OR ;Timepoint(s) of evaluation of this end point: Follow-up on patients will be done at the following points in time: 10 days (+-3 days) after surgery 1 months (+- 7 days) after surgery 3 months (+- 7 days) after surgery 6 months (+- 14 days) after surgery 12 months (+- 14 days) after surgery	—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 11, 2026