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Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Primary Purpose

Surgical Site Infections

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Prolonged antibiotic treatment

Short antibiotic course (standard of care)

About this trial

This is an interventional prevention trial for Surgical Site Infections focused on measuring surgical site infection, breast reconstruction, drains, prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

All criteria should be present:

Signing an informed consent form
Reconstructive breast surgery
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

Sites / Locations

Department of plastic surgery, Sheba medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

short antibiotic course

Prolonged antobiotic treatment

Arm Description

Intravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery

Intravenous 2 gram cefazolin every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02012517

First Posted

December 5, 2013

Last Updated

December 13, 2013

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02012517

Brief Title

Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Official Title

Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infections

Keywords

surgical site infection, breast reconstruction, drains, prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

short antibiotic course

Arm Type

Active Comparator

Arm Description

Intravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery

Arm Title

Prolonged antobiotic treatment

Arm Type

Experimental

Arm Description

Intravenous 2 gram cefazolin every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains

Intervention Type

Drug

Intervention Name(s)

Prolonged antibiotic treatment

Other Intervention Name(s)

Intravenous cefazolin 2 grams every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains

Intervention Type

Drug

Intervention Name(s)

Short antibiotic course (standard of care)

Other Intervention Name(s)

Intravenous cefazolin 2 grams every 8 hours for 24 hours starting at surgery

Primary Outcome Measure Information:

Title

surgical site infection

Description

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

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All criteria should be present: Signing an informed consent form Reconstructive breast surgery 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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yasmin Maor, MD

yasmin.maor@sheba.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasmin Maor, MD

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of plastic surgery, Sheba medical center

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

12. IPD Sharing Statement

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Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

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