Current Surgical Practices and Surgical Site Infection at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03761459

Collaborator

Mekelle University (Other)

1,240

Enrollment

Location

45.4

Anticipated Duration (Months)

27.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Infection Infected Wound Surgical Site Infection Surgery--Complications Surgery Surgical Wound

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Current Surgical Practices and Surgical Site Infection at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia

Actual Study Start Date :

Mar 20, 2018

Anticipated Primary Completion Date :

Jun 20, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Outcome Measures

Primary Outcome Measures

Adherence to World Health Organization (WHO) Surgical Unit based Safety Programme (SUSP) guidelines [12 months]
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

Secondary Outcome Measures

Surgical site infection incidence at ACSH [30 days from operation]
Determine the current surgical site infection rate at ACSH through prospective data collection of operations occurring at ACSH during the study period
Trends between adherence to WHO SUSP guidelines and infection [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)