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Improved Perioperative Preventive Measures for Surgical Site Infections (BASIC Trial)

N/A

Recruiting

Led By Jeremiah R Brown, PhD

Research Sponsored by Trustees of Dartmouth College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

orthopedic total joint and spine procedures

Be older than 18 years old

Must not have

no requirement for anesthesia and/or placement of a peripheral intravenous catheter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up peri-operative

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a multifaceted program to see if it can reduce surgical site infections (SSIs). The program includes improved basic perioperative preventive measures. The investigators aim to examine the relative effectiveness of each component of this program in controlling ESKAPE transmission and reducing SSIs and to identify an optimal implementation strategy for national dissemination.

Who is the study for?

This trial is for patients undergoing elective orthopedic total joint or spine surgeries. It includes surgeons performing these procedures and operating rooms conducting them. Patients must need anesthesia, have an incision, and give written consent. Those with allergies to certain antiseptics or a high ASA health classification, as well as centers in other infection prevention trials, can't join.

What is being tested?

The study tests the effectiveness of technical assistance versus team-based coaching on preventing bacterial transmission and infections after surgery. The focus is on ESKAPE pathogens known for resistance and virulence. Hospitals are randomly chosen to adopt different preventative programs to find the best approach for national use.

What are the potential side effects?

Since this trial involves implementation strategies rather than drugs, traditional side effects aren't expected. However, there may be indirect impacts related to changes in hospital routines or surgical practices that could affect patient experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery on my joints or spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't need anesthesia or an IV line for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90-day postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90-day postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90-day postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ESKAPE Transmission Events

Secondary study objectives

Surgical Site Infection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Technical Assistance No SurveillanceActive Control1 Intervention

TA will be offered to 3 teams. TA will have monthly scheduled TA calls (60 minutes each) with each team individually to review and discuss the protocol interventions (as is done in the EBIP group) and allow for a consultation with experts on the peri-operative interventions. Surveillance toolkit will only be used for transmission data collection.

Group II: Surveillance with Technical AssistanceActive Control1 Intervention

Surveillance will be offered to 3 teams with Technical Assistance (TA) in block randomization. Surveillance tool will execute regularly updated reports (continually updated with laboratory data entry of ESKAPE pathogen isolation results), which generates a set of data that will populate series of tables and graphs for each site based on data collection form as previously reported.

Group III: Surveillance with EBIP CoachingActive Control1 Intervention

Surveillance will be offered to 3 teams with Evidence-Based Infection Prevention Bundle (EBIP) coaching in block randomization. Surveillance tool will execute regularly updated reports (continually updated with laboratory data entry of ESKAPE pathogen isolation results), which generates a set of data that will populate series of tables and graphs for each site based on data collection form as previously reported. EBIP involves evidence-based improvements in perioperative hand hygiene, environmental cleaning, vascular care, and patient decolonization. Each participating site will receive monthly team-based coaching to establish a multidisciplinary team charged with continuously improving transmission and infection prevention.

Group IV: EBIP Coaching No SurveillanceActive Control1 Intervention

EBIP will be offered to 3 teams. Each participating site will receive monthly team-based coaching to establish a multidisciplinary team charged with continuously improving transmission and infection prevention. EBIP involves evidence-based improvements in perioperative hand hygiene, environmental cleaning, vascular care, and patient decolonization. Surveillance toolkit will only be used for transmission data collection.

0 / 2Eligibility criteria met