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

Phase 1

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.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-004878-26-SE

Lead Sponsor: Karolinska University Hospital Solna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 870

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>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:<br>10 days (+-3 days) after surgery<br>1 months (+- 7 days) after surgery<br>3 months (+- 7 days) after surgery<br>6 months (+- 14 days) after surgery<br>12 months (+- 14 days) after surgery

Secondary Outcome Measures

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