Surgical Site Infection and Antibiotic Use Study

NCT04631185 | Completed

• 1 other identifier: PSF 19-03-SSI Study
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients will be randomly assigned to one of the two treatment groups. One group will receive a single dose of antibiotics just before surgery and if necessary, more doses during the surgery. The other group will receive the same treatment as the first group, along with an additional week of antibiotics after surgery. The study will assess the rates of SSI from the two groups. It will also assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group.

Conditions

Surgical Site Infection; Breast Reconstruction; Antibiotic Use

Outcome Measures

Primary Outcomes (1)

• Number of participants in each group who develop surgical site infection (SSI) within 30 days of index procedure.

  Surgical site infection as defined by CDC criteria within 30 days after the index procedure

  Up to 30 days after the index procedure

Secondary Outcomes (6)

• Number of participants in each group with antibiotic-related adverse events and the type of adverse events reported.

  Up to 30 days after the index procedure

• Number of participants in each group who develop an SSI or other complications after 30 days of index procedure.

  Up to two years

• Number of participants in each group who undergo premature tissue expander or implant removal.

  From index procedure until expander removal

• Type, duration and route of antibiotic administration (Oral or Intravenous) in participants in each group who develop SSI/deep infections.

  Up to two Years

• Comparison of any secondary infections, including resistant bacterial strains and yeast infections, in participants from the two groups who develop SSI.

  Up to two Years

Study Arms (2)

SPD (Arm A)

ACTIVE COMPARATOR

Single pre-operative dose of intravenous antibiotics with intraoperative redosing (SPD): Intravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. All patients will receive one dose of antibiotic within 60 minutes prior to incision, and any intraoperative doses of antibiotics according to current recommendations based on the antibiotic's dosing and on operative time.

Drug: Single pre-operative dose of intravenous antibiotics with intraoperative redosing

WPO (Arm B)

EXPERIMENTAL

The patients assigned to this arm will receive same pre-op and intraoperative antibiotics similar to SPD (Arm A). In addition, patients in this group will receive one week of post-operative antibiotics (WPO). The post-operative antibiotic will be a first generation Cephalosporin of their surgeon's choice.

Drug: Single pre-operative dose of intravenous antibiotics with intraoperative redosing; Drug: One week of post-operative antibiotics

Interventions

Single pre-operative dose of intravenous antibiotics with intraoperative redosing DRUG

Intravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. In case of allergy to cefazolin, intravenous clindamycin will be prescribed. For allergy to both antibiotics, an appropriate antibiotic should be chosen by the surgeon and documented. All patients will receive one dose of antibiotic within 60 minutes prior to incision, and any intraoperative doses of antibiotics according to current recommendations based on the antibiotic's dosing and on operative time.

SPD (Arm A); WPO (Arm B)

One week of post-operative antibiotics DRUG

The patients will be prescribed one week of Cephalosporin Antibiotic (Keflex/Duricef/Other) of their surgeon's choice.

WPO (Arm B)

Eligibility Criteria

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

You may qualify if:

• Women 18 years or older, undergoing unilateral or bilateral mastectomy (including breast cancer, any stage, or prophylactic) and immediate tissue expander reconstruction (including submuscular, submuscular and ADM, or pre-pectoral placement).

You may not qualify if:

• Breast cancer patients not undergoing mastectomy
• Patients undergoing direct-to-implant reconstruction
• Patients undergoing delayed reconstruction
• Patients having autologous reconstruction
• History of radiation to the breast or chest
• History of previous breast reconstruction on the side of expander placement
• Patients with serious existing systemic infection, defined as 2 or more of the following: Peripheral body temperature \>38 degrees Celsius CRP \>5g/L Leukocytes \> 12,000/microliter at the time of enrollment.

Sponsors & Collaborators

• The Plastic Surgery Foundation: lead

Study Sites (5)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Officials

• Christine Rohde, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Brian Gastman, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: May 7, 2021
• Primary Completion: December 31, 2023
• Study Completion: May 20, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)