Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

NCT02012517 | Unknown Phase 4

• 1 other identifier: 0447-13-SMC
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infections

Keywords

surgical site infection; breast reconstruction; drains; prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

short antibiotic course

ACTIVE COMPARATOR

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

Drug: Short antibiotic course (standard of care)

Prolonged antobiotic treatment

EXPERIMENTAL

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

Drug: Prolonged antibiotic treatment

Interventions

Prolonged antibiotic treatment DRUG

Also known as: 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

Prolonged antobiotic treatment

Short antibiotic course (standard of care) DRUG

Also known as: Intravenous cefazolin 2 grams every 8 hours for 24 hours starting at surgery

short antibiotic course

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All criteria should be present:
• Signing an informed consent form
• Reconstructive breast surgery
• One drain or more remained after surgery -

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Department of plastic surgery, Sheba medical center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yasmin Maor, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmin Maor, MD

CONTACT

yasmin.maor@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the infectious didease service to the hospitalized patient, infectious disease unit

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 16, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

IL (1)