Improved Perioperative Preventive Measures for Surgical Site Infections

(BASIC Trial)

Recruiting at 2 trial locations

Overseen By Iben Sullivan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Dartmouth College

Disqualifiers: No anesthesia, Chlorhexidine allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different strategies to prevent infections after surgeries, such as joint replacements or spine operations. The study aims to determine which combination of support and coaching methods best prevents harmful bacteria from causing infections. Participants will join a site that receives either technical guidance, team-based coaching, or a mix of both to improve practices like hand hygiene and cleaning. Individuals undergoing elective orthopedic total joint or spine surgeries might be suitable for this trial, especially if they have no allergies to certain cleaning products or anesthesia requirements.

As an unphased trial, this study allows participants to contribute to innovative strategies that could enhance surgical outcomes and prevent infections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these perioperative preventive measures are safe?

Research has shown that technical help and team coaching can lower the risk of surgical site infections (SSIs) after surgery. One study found that a program using these methods reduced SSIs by 88% compared to regular care. These methods focus on improving practices such as handwashing and environmental cleaning.

In terms of safety, these approaches are generally safe because they involve training and coaching rather than medication. A study on training for infection prevention reported good results without any side effects. This indicates that these methods are safe and aim to enhance current procedures without adding risks.

These methods are already in use in healthcare to improve patient outcomes, and no evidence suggests harm from participating in such programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to prevent surgical site infections, a common and serious complication after surgery. Unlike traditional methods that focus solely on individual practices, this trial tests team-based approaches like Technical Assistance (TA) and Evidence-Based Infection Prevention Bundle (EBIP) coaching. These approaches emphasize team collaboration and comprehensive strategies, such as improving hand hygiene, environmental cleaning, and patient decolonization. By incorporating real-time data surveillance and expert coaching, these methods aim to create a dynamic environment where surgical teams can continuously refine and improve their infection prevention techniques. This could lead to more effective, adaptable solutions for keeping surgical sites infection-free.

What evidence suggests that this trial's treatments could be effective in reducing surgical site infections?

Research has shown that better preventive steps during surgery can greatly lower the risk of infections at the surgical site. One study found that a comprehensive program to improve basic practices during surgery reduced these infections by 88% compared to standard care. This trial will compare different approaches to infection prevention. Some participants will receive technical assistance without surveillance, while others will receive surveillance with technical assistance or EBIP coaching. Key parts of these strategies include proven methods like proper handwashing and cleaning the environment. These steps help keep patients safer and reduce the risk of infections after surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Jeremiah R Brown, PhD

Principal Investigator

Trustees of Dartmouth College

Randy Loftus, MD

Principal Investigator

Mayo Clinic

Ib en K Sullivan, PhD

Principal Investigator

Trustees of Dartmouth College

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Total N=6,000

250 patients (125 case pairs) per site in the active phase (N=3,000)

I am scheduled for elective orthopedic surgery on a joint or spine.

Exclusion Criteria

lack of incision or informed, written consent

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of a multifaceted, evidence-based, peri-operative surgical site infection preventive program

Varies by site

Monthly team-based coaching sessions

Surveillance

Surveillance tool executes regularly updated reports for ESKAPE pathogen isolation results

Throughout the trial

Follow-up

Participants are monitored for surgical site infections up to 90 days postoperatively

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Technical assistance or team-based coaching

Trial Overview 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.

How Is the Trial Designed?

Group I: Technical Assistance No Surveillance Active Control 1 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 Assistance Active Control 1 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 Coaching Active Control 1 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 Surveillance Active Control 1 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.

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Published Research Related to This Trial

Strict adherence to prophylactic antibiotic guidelines is crucial for reducing the risk of surgical site infections, which are common and can lead to complications like prolonged recovery and increased healthcare costs.

Monitoring patients' oxygenation status and body temperature, along with diligent follow-up of surgical wounds after discharge, can significantly enhance the prevention of surgical site infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving issues in the prevention of surgical site infections. Quinn, A., Hill, AD., Humphreys, H.[2019]

In a study of 2,403 patients across 35 hospitals, adherence to a colorectal surgical site infection (SSI) reduction bundle was found to be influenced by patient characteristics, such as BMI, with obese patients showing higher adherence rates compared to underweight patients.

Patients treated at safety net hospitals had significantly lower adherence to the SSI reduction bundle, indicating that these institutions may face unique challenges that require targeted strategies to improve implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Patient and Hospital Characteristics and Adherence to a Surgical Site Infection Reduction Bundle in a Statewide Surgical Quality Improvement Collaborative. Brajcich, BC., Schlick, CJR., Halverson, AL., et al.[2023]

The Surgical Care Improvement Project (SCIP) has not significantly reduced surgical site infections despite promoting effective antibiotic recommendations since 2006, indicating a gap between evidence and practice.

To improve outcomes, the focus should shift from merely reporting adherence to metrics towards fostering local and regional collaborations that educate clinicians on practical improvements in their practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Surgical Care Improvement Project Antibiotic Guidelines: Should We Expect More Than Good Intentions? Schonberger, RB., Barash, PG., Lagasse, RS.[2018]

Implementing a tailored antibiotic prophylaxis form led to over 90% compliance with Surgical Care Improvement Project (SCIP) measures, significantly reducing variability in antibiotic ordering practices for surgical patients.

The multidisciplinary approach not only improved compliance and standardization of perioperative antibiotic use but also resulted in estimated annual savings of $8500 on surgical prophylaxis costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving antibiotic stewardship: order set implementation to improve prophylactic antimicrobial prescribing in the outpatient surgical setting. Braxton, CC., Gerstenberger, PA., Cox, GG.[2010]

Surgical site infections (SSIs) occur in about 1-3% of elective clean surgeries, and while patient factors play a role, external factors are also significant in their development.

Preventing SSIs requires a comprehensive approach that includes proper use of prophylactic antibiotics and active post-discharge monitoring, as well as implementing evidence-based guidelines and safety checklists across all stages of patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing surgical site infections. Uçkay, I., Harbarth, S., Peter, R., et al.[2022]

A comprehensive glycemic control initiative significantly reduced surgical site infections (SSI) from 14.6% to 5.7% in patients undergoing major pelvic surgery for gynecologic malignancies, based on a study of 462 patients.

The initiative also led to the early identification of diabetes or prediabetes in approximately 19% of patients, highlighting its role in improving overall patient health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a referral to discharge glycemic control initiative for reduction of surgical site infections in gynecologic oncology patients. Hopkins, L., Brown-Broderick, J., Hearn, J., et al.[2022]

A hospital significantly improved compliance with the Surgical Care Improvement Project (SCIP) antibiotic guidelines within a year, leading to enhanced patient safety and earning over $290,000 in 2011 and $209,000 in 2012 for reinvestment in safety initiatives.

Implementing low-cost educational interventions for providers not only improved SCIP compliance but also resulted in substantial annual cost savings, although the direct impact on infection rates needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process measures to improve perioperative prophylactic antibiotic compliance: quality and financial implications. Sutherland, T., Beloff, J., Lightowler, M., et al.[2019]

An educational campaign using a quality improvement tool led to an increase in timely prophylactic antibiotic administration from 54% to 68% among surgical patients, indicating improved adherence to guidelines.

Post-intervention, appropriate postoperative antibiotic prescribing also improved significantly from 71% to 92%, suggesting that the educational efforts were effective in enhancing surgical site infection prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving surgical site infection prevention practices through a multifaceted educational intervention. Owens, P., McHugh, S., Clarke-Moloney, M., et al.[2015]

Despite the implementation of evidence-based guidelines for preventing surgical site infections (SSIs), such as those from NICE and SCIP, SSI rates have not significantly decreased, indicating a gap between guidelines and actual practice.

The care bundle approach, which includes key measures like proper hair removal, antibiotic prophylaxis, and effective skin preparation, is recommended to improve compliance, but reasons for poor adherence to these practices remain unclear, highlighting the need for further research and better communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical site infection: poor compliance with guidelines and care bundles. Leaper, DJ., Tanner, J., Kiernan, M., et al.[2023]

Surgical site infections (SSIs) can lead to significant healthcare costs and complications, making effective prevention strategies essential, including environmental cleaning, instrument sterilization, and preoperative decolonization of Staphylococcus aureus.

Collaboration among healthcare professionals and timely reporting of SSI rates are crucial for enhancing infection prevention efforts, allowing for the development of targeted programs aimed at reducing SSIs and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices and a Business Case for Surgical Site Infection Prevention. Kang, M., Andrew, ME., Farishta, A., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/search/JbRgAtchAUKHOoW2X1vObQ/project-details/11098544

RePORT RePORTER - National Institutes of Health (NIH) | Perioperative ESKAPE transmission (inoculum) contributes to the development of surgical site infections (SSIs) which affect 3-5% of patients undergoing surgery.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04600973

Improving Implementation of Evidence-based Approaches ... Main comparison in delivering peri-operative preventive strategies against transmission and infection is one on one technical assistance or team-based coaching.

3. withpower.com withpower.com/trial/phase-infections-6-2021-8ae5a

Improved Perioperative Preventive Measures for Surgical Site ... Trial Overview The study tests the effectiveness of technical assistance versus team-based coaching on preventing bacterial transmission and infections after ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0964339724003124

A quality improvement program to reduce surgical site ... A quality improvement initiative encompassing measurements at all levels potentially impacting SSI risk was implemented over a 2.5 years period.

5. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2022/02000/use_of_feedback_data_to_reduce_surgical_site.38.aspx

Use of Feedback Data to Reduce Surgical Site Infections ... Feedback on practices and outcomes is known to be key to reduce SSI rates and optimize antibiotic usage.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4610798/

Reducing the risk of surgical site infection using a ... To identify and describe the strategies and processes used by multidisciplinary teams of health care professionals to reduce surgical site infections (SSIs).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961019315843

Teaching in the operating room: A risk for surgical site ... Out of a total of 4560 patients/surgeries, 1403 (30.8%) were classified as teaching operations. The overall SSI rate was 5.1% (n = 233). Teaching operations (OR ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9424564/

Task-based training to prevent surgical site infection The purpose of this study was to design and implement an infection prevention training programme and investigate how it might work in an LMIC.

9. cdc.gov cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

Surgical Site Infection Event (SSI) Based on the 2023 HAI data results published in the NHSN's HAI Progress Report, about a 2% increase in the SSI standardized infection ratio ...