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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02012517
Other study ID # 0447-13-SMC
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received December 5, 2013
Last updated December 13, 2013
Start date January 2014
Est. completion date December 2017

Study information

Verified date December 2013
Source Sheba Medical Center
Contact Yasmin Maor, MD
Email yasmin.maor@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing breast reconstruction who have drains placed for several days after surgery is controversial. In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains. Patients will sign an informed consent form prior to the surgery and will be randomized to one of the antibiotic regimens. Patients will be closely followed up to one year after surgery. The number of surgical site infections according to the NNIS criteria and loss of breast implants will be compared between the two groups.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 160
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

All criteria should be present:

1. Signing an informed consent form

2. Reconstructive breast surgery

3. One drain or more remained after surgery -

Exclusion Criteria:

Age < 18 years Active infection at the surgical site at the operation time or in close proximity to the surgical site Immune deficiency state

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Prolonged antibiotic treatment

Short antibiotic course (standard of care)


Locations

Country Name City State
Israel Department of plastic surgery, Sheba medical center Tel Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary surgical site infection The percentage and number of surgical site infections assessed according to the NNIS criteria up to one year after reconstructive breast surgery will be compared between the two groups 1 year No
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