An observational study in Surgical Wound Infection, Infected Wound and Surgical Site Infection, sponsored by University of Illinois at Chicago. Active, not recruiting at 1 site in Ethiopia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-08.
Sponsored by University of Illinois at Chicago · Observational
This study evaluates the current surgical practices at Ayder Comprehensive Specialized Hospital in comparison to the World Health Organization's Surgical Unit Based Safety Programme guidelines and aims to determine how deviations from those guidelines are associated with varying rates of surgical site infection incidence in this population. The results of this study will help elucidate risk factors for surgical site infection and prioritize future interventions to decrease the rate of surgical site infection at Ayder Comprehensive Specialized Hospital, as well as other low and middle-income hospitals. The data collected regarding surgical site infection rates will also prove beneficial in measuring outcomes of any interventions that are developed as a result of this study.
Surgical site infection continues to be a major cause of morbidity and mortality around the world with low and middle-income countries disproportionately affected with rates as high as 30-40% compared to an average rate of less than 3% in high income countries. In addition to the grave clinical implications of these infections, the additional costs incurred by both patients and treating institutions can be catastrophic.
The World Health Organization's "Clean Care is Safer Care" initiated quality improvement projects in five African hospitals between 2013 and 2015, demonstrating that low-cost interventions can decrease the rates of surgical site infection in low and middle-income countries. This successful initiative formed the basis of the World Health Organization's Surgical Unit Based Safety Programme guidelines.
This will be a prospective cohort study collecting data about surgical practices, pre- and post-operative care and post-operative infection from time of admission through post-operative day 30. Patients will be identified when they are scheduled for surgery and undergo consent process. If they consent to participate in the study their clinical course will be followed through post-operative day 30. Inpatient observational data will be collected to determine whether current practices are in line with World Health Organization's Surgical Unit Based Safety Programme guidelines. Potential confounding risk factors for infection will be identified, and post-operative information will be collected through inpatient follow up as well as telephone calls on post-operative day ten and 30 to assess for signs or symptoms of surgical site infection.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 1,240 is above the median of 240 across 2,136 observational studies indexed under Infections.
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Male and female patients 18 years of age or older undergoing any surgical procedure in the main operating theaters at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia during the 12-month study period, not including cases involving permanent implants. Inpatient collection of data will occur prospectively with supplemental information recorded from medical records if patient consents. Post-discharge data will be collected for patients who consent for follow-up.
Exclusion Criteria:
Adherence to World Health Organization (WHO) Surgical Unit based Safety Programme (SUSP) guidelines
Determine whether current surgical practices at Ayder Comprehensive Specialized Hospital (ACSH) follow each of the six components of the WHO SUSP guidelines through prospective data collection via case report form, which is filled out by trained data collector during procedure and during the post-operative period to document whether each of the SUSP guidelines are being followed
Time frame: 12 months
Surgical site infection incidence at ACSH
Determine the current surgical site infection rate at ACSH through prospective data collection of operations occurring at ACSH during the study period
Time frame: 30 days from operation
Trends between adherence to WHO SUSP guidelines and infection
Evaluate trends between surgical site infection and the adherence to each of the WHO SUSP guideline components using logistic regression analysis of prospectively collected data regarding adherence to WHO SUSP guidelines and occurrence of post-operative infection
Time frame: 12 months
Plan to share: No — Individual participant data will not be available to anyone outside of our study.
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago