The Role of Guideline-adherent Perioperative Antibiotic Administration and the Risk of Surgical Site Infections After Non-cardiac Surgery.

NCT03982810 | Withdrawn DMC

• 1 other identifier: 2000023706
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will seek to describe current practice of antibiotic prophylaxis to identify the effect of appropriate perioperative antimicrobial coverage - specifically regarding timing, dose adjustments, and redosing - on surgical site infections (SSI).

Conditions

Surgical Site Infection; Antibiotic Prophylaxis

Outcome Measures

Primary Outcomes (3)

• Lower incidence of SSI due to timing

  To identify the effect of appropriate perioperative antimicrobial coverage - specifically regarding timing

  7 years

• Lower incidence of SSI due to dose adjustments

  To identify the effect of appropriate perioperative antimicrobial coverage - specifically regarding dose adjustments

  7 years

• Lower incidence of SSI due to redosing

  To identify the effect of appropriate perioperative antimicrobial coverage - specifically regarding redosing.

  7 years

Study Arms (1)

Surgical Site Infections

Patients equal or greater than 18 years of age undergoing non-emergent non-cardiac surgical procedures involving a skin incision will be included in the study.

Drug: Antibiotics

Interventions

Antibiotics DRUG

Antibiotic prophylaxis and the occurrence of a NSQIP-adjudicated SSI during the period from 2011 to 2018. SSIs will be a composite of superficial (only skin or subcutaneous tissue of the incision), deep (deep soft tissues), and organ space (any part of the anatomy other than the incision, which has been opened and manipulated during the operation), as provided by the NSQIP.

Also known as: antibiotic prophylaxis

Surgical Site Infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be accessed from the international consortium known as the Multicenter Perioperative Outcomes Group (MPOG), which consists of 44 active sites from the US and Europe that is based out of the University of Michigan where primary IRB oversight exists. The present project will also include the analysis of data from the MPOG consortium of data from some participating institutions' National Surgical Quality Improvement Program (NSQIP). Those data have been merged with MPOG data. The population will be limited to datasets for subjects undergoing general vascular surgery for the last 7 years.

You may qualify if:

• All patients equal or greater than 18 years of age
• Undergoing non-emergent non-cardiac surgical procedures involving a skin incision

You may not qualify if:

• Emergency surgery
• Open wound with or without infection
• Current active infection
• Transfusion of 4 or more units of packed red blood cells during surgery
• Preoperative sepsis or systemic inflammatory response syndrome within 48 hours prior to surgery 6 Ventilator dependence within 48 hours of surgery 7 Surgery within preceding 30 days 8 Ongoing preoperative antibiotic therapy 9 Missing perioperative antibiotic/medication documentation 10 Ophthalmic surgeries 11 Organ Transplants 12 Organ harvesting surgeries 13 ASA 5,6 14 Cardiac Surgeries 15 Age \<18 years
• Emergency surgery
• Ongoing preoperative antibiotic therapy 3. Missing perioperative antibiotic/medication documentation
• Ophthalmic surgeries 5 Lung Transplants 6 Organ harvesting surgeries 7 ASA 5,6 8 Cardiac surgeries 9 Age\<18 years

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Anti-Bacterial Agents; Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Chemoprevention; Drug Therapy; Therapeutics; Premedication

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: June 1, 2019
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)