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

May 4, 2023 updated by: Erin Cavanaugh, University of Illinois at Chicago
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Tigray
      • Mekele, Tigray, Ethiopia
        • Ayder Comprehensive Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to World Health Organization (WHO) Surgical Unit based Safety Programme (SUSP) guidelines
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection incidence at ACSH
Time Frame: 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
30 days from operation
Trends between adherence to WHO SUSP guidelines and infection
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Mekelle University

Investigators

  • Principal Investigator: Erin Cavanaugh, MD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2018

Primary Completion (Actual)

October 8, 2019

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (Actual)

December 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to anyone outside of our study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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