Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Surgical Site Infections Clinical Trial

Official title:

Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02012517
• Other study ID #: 0447-13-SMC
• 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

• Surgical Site Infections
• Surgical Wound Infection

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