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

NCT03761459 | Unknown

• 1 other identifier: 2017-1251
• Study Type: observational
• Target: 1,240
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

• Surgical site infection incidence at ACSH

  30 days from operation

• Trends between adherence to WHO SUSP guidelines and infection

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Mekelle University: collaborator

Study Sites (1)

Ayder Comprehensive Referral Hospital

Mek'ele, Tigray, Ethiopia

Location

Related Publications (15)

• Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.

  PMID: 10219875 BACKGROUND

• Astagneau P, Rioux C, Golliot F, Brucker G; INCISO Network Study Group. Morbidity and mortality associated with surgical site infections: results from the 1997-1999 INCISO surveillance. J Hosp Infect. 2001 Aug;48(4):267-74. doi: 10.1053/jhin.2001.1003.

  PMID: 11461127 BACKGROUND

• Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.

  PMID: 10580621 BACKGROUND

• Coello R, Charlett A, Wilson J, Ward V, Pearson A, Borriello P. Adverse impact of surgical site infections in English hospitals. J Hosp Infect. 2005 Jun;60(2):93-103. doi: 10.1016/j.jhin.2004.10.019.

  PMID: 15866006 BACKGROUND

• Gaynes RP, Culver DH, Horan TC, Edwards JR, Richards C, Tolson JS. Surgical site infection (SSI) rates in the United States, 1992-1998: the National Nosocomial Infections Surveillance System basic SSI risk index. Clin Infect Dis. 2001 Sep 1;33 Suppl 2:S69-77. doi: 10.1086/321860.

  PMID: 11486302 BACKGROUND

• Ngaroua, Ngah JE, Benet T, Djibrilla Y. [Incidence of surgical site infections in sub-Saharan Africa: systematic review and meta-analysis]. Pan Afr Med J. 2016 Jun 29;24:171. doi: 10.11604/pamj.2016.24.171.9754. eCollection 2016. French.

  PMID: 27795768 BACKGROUND

• Chu K, Maine R, Trelles M. Cesarean section surgical site infections in sub-Saharan Africa: a multi-country study from Medecins Sans Frontieres. World J Surg. 2015 Feb;39(2):350-5. doi: 10.1007/s00268-014-2840-4.

  PMID: 25358418 BACKGROUND

• Amenu D, Belachew T, Araya F. Surgical site infection rate and risk factors among obstetric cases of jimma university specialized hospital, southwest ethiopia. Ethiop J Health Sci. 2011 Jul;21(2):91-100. doi: 10.4314/ejhs.v21i2.69049.

  PMID: 22434989 BACKGROUND

• Mengesha RE, Kasa BG, Saravanan M, Berhe DF, Wasihun AG. Aerobic bacteria in post surgical wound infections and pattern of their antimicrobial susceptibility in Ayder Teaching and Referral Hospital, Mekelle, Ethiopia. BMC Res Notes. 2014 Aug 27;7:575. doi: 10.1186/1756-0500-7-575.

  PMID: 25164127 BACKGROUND

• Wasihun AG, Zemene Y. Bacterial profile and antimicrobial susceptibility patterns of otitis media in Ayder Teaching and Referral Hospital, Mekelle University, Northern Ethiopia. Springerplus. 2015 Nov 14;4:701. doi: 10.1186/s40064-015-1471-z. eCollection 2015.

  PMID: 26609503 BACKGROUND

• Aiken AM, Karuri DM, Wanyoro AK, Macleod J. Interventional studies for preventing surgical site infections in sub-Saharan Africa - A systematic review. Int J Surg. 2012;10(5):242-9. doi: 10.1016/j.ijsu.2012.04.004. Epub 2012 Apr 14.

  PMID: 22510442 BACKGROUND

• Teshager FA, Engeda EH, Worku WZ. Knowledge, Practice, and Associated Factors towards Prevention of Surgical Site Infection among Nurses Working in Amhara Regional State Referral Hospitals, Northwest Ethiopia. Surg Res Pract. 2015;2015:736175. doi: 10.1155/2015/736175. Epub 2015 Dec 15.

  PMID: 26788549 BACKGROUND

• Aiken AM, Wanyoro AK, Mwangi J, Mulingwa P, Wanjohi J, Njoroge J, Juma F, Mugoya IK, Scott JA, Hall AJ. Evaluation of surveillance for surgical site infections in Thika Hospital, Kenya. J Hosp Infect. 2013 Feb;83(2):140-5. doi: 10.1016/j.jhin.2012.11.003. Epub 2013 Jan 18.

  PMID: 23332563 BACKGROUND

• Nguhuni B, De Nardo P, Gentilotti E, Chaula Z, Damian C, Mencarini P, Nicastri E, Fulment A, Piscini A, Vairo F, Aiken AM, Ippolito G. Reliability and validity of using telephone calls for post-discharge surveillance of surgical site infection following caesarean section at a tertiary hospital in Tanzania. Antimicrob Resist Infect Control. 2017 May 8;6:43. doi: 10.1186/s13756-017-0205-0. eCollection 2017.

  PMID: 28503302 BACKGROUND

• Hurwitz EE, Simon M, Vinta SR, Zehm CF, Shabot SM, Minhajuddin A, Abouleish AE. Adding Examples to the ASA-Physical Status Classification Improves Correct Assignment to Patients. Anesthesiology. 2017 Apr;126(4):614-622. doi: 10.1097/ALN.0000000000001541.

  PMID: 28212203 BACKGROUND

Related Links

• Surveillance of surgical site infections in Europe, 2008-2009 by the European Centre for Disease Prevention and Control
• Microbial contamination of operating theatre at Ayder Referral Hospital, Northern Ethiopia. International Journal of Pharma Sciences and Research, 6(10), 1264-1267
• SUSP project in African Surgical Departments

MeSH Terms

Conditions

Surgical Wound Infection; Wound Infection; Surgical Wound

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Erin Cavanaugh, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: March 20, 2018
• Primary Completion: October 8, 2019
• Study Completion: December 30, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)