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Improved Perioperative Preventive Measures for Surgical Site Infections (BASIC Trial)
N/A
Recruiting
Led By Randy Loftus, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up peri-operative
Awards & highlights
BASIC Trial 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.Check my eligibility
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.See study design
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.
BASIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had surgery on my joints or spine.
BASIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90-day postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90-day postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ESKAPE Transmission Events
Secondary outcome measures
Surgical Site Infection
BASIC 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.
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,208 Previous Clinical Trials
3,761,050 Total Patients Enrolled
28 Trials studying Infections
7,508 Patients Enrolled for Infections
Georgetown UniversityOTHER
343 Previous Clinical Trials
130,502 Total Patients Enrolled
1 Trials studying Infections
11 Patients Enrolled for Infections
University of IowaOTHER
446 Previous Clinical Trials
873,502 Total Patients Enrolled
7 Trials studying Infections
5,075 Patients Enrolled for Infections
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for elective orthopedic surgery on a joint or spine.You are currently participating in a clinical trial focused on preventing or treating bacterial infections.I am not allergic to povidone iodine or isopropyl alcohol.My surgery will be on a joint or spine by an orthopedic surgeon.I don't need anesthesia or an IV line for treatment.I have had surgery on my joints or spine.My surgery will be for a joint replacement or spine in an operating room.
Research Study Groups:
This trial has the following groups:- Group 1: Technical Assistance No Surveillance
- Group 2: Surveillance with Technical Assistance
- Group 3: Surveillance with EBIP Coaching
- Group 4: EBIP Coaching No Surveillance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any patient enrollment availability in this trial?
"As per clinicaltrials.gov, this medical trial is not currently accepting participants. It was first posted on July 1st 2021 and had its last update on February 3rd 2022. Nevertheless, there are 793 other trials that require volunteers in the present moment."
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