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Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

NCT ID: NCT02012517

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Site Infections

Keywords

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surgical site infection breast reconstruction drains prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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short antibiotic course

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

Group Type ACTIVE_COMPARATOR

Short antibiotic course (standard of care)

Intervention Type DRUG

Prolonged antobiotic treatment

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

Group Type EXPERIMENTAL

Prolonged antibiotic treatment

Intervention Type DRUG

Interventions

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Prolonged antibiotic treatment

Intervention Type DRUG

Short antibiotic course (standard of care)

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Yasmin Maor

Head of the infectious didease service to the hospitalized patient, infectious disease unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasmin Maor, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Department of plastic surgery, Sheba medical center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yasmin Maor, MD

Role: CONTACT

Email: [email protected]

Other Identifiers

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0447-13-SMC

Identifier Type: -

Identifier Source: org_study_id