Clinical trial NCT03761459: Current Surgical Practices and Surgical Site Infection at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia
Official title: Current Surgical Practices and Surgical Site Infection at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Wound Infection
Infected Wound
Surgical Site Infection
Surgery--Complications
Surgery
Surgical Wound
Keywords: Surgical site infection
low and middle income country
low resource setting
Africa
Ethiopia
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Mekelle University
First posted: 2018-12-03
Enrollment: 1240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients (male and female) 18 years of age or older undergoing any surgery (elective, scheduled, urgent or emergent) including obstetrics and gynecology cases at ACSH in Mekelle Ethiopia.

Exclusion Criteria:

* Patients under the age of 18.
* Patients who undergo surgery involving permanent implants (as these patients would require follow up for 1 year to effectively rule out surgical site infection and this is beyond the data collection time frame of this study)

Primary outcomes:
measure: Adherence to World Health Organization (WHO) Surgical Unit based Safety Programme (SUSP) guidelines
timeFrame: 12 months
Secondary outcomes:
measure: Surgical site infection incidence at ACSH
timeFrame: 30 days from operation
measure: Trends between adherence to WHO SUSP guidelines and infection
timeFrame: 12 months
Other outcomes:
Locations:
city: Mekele
country: Ethiopia
facility: Ayder Comprehensive Referral Hospital
state: Tigray
Study officials:
affiliation: University of Illinois at Chicago
name: Erin Cavanaugh, MD
role: PRINCIPAL_INVESTIGATOR
References:
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