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

NCT ID: NCT03761459

Last Updated: 2023-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-20

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Surgical Wound Infection Infected Wound Surgical Site Infection Surgery--Complications Surgery Surgical Wound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mekelle University

OTHER

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Erin Cavanaugh

Assistant Professor, Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erin Cavanaugh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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Ayder Comprehensive Referral Hospital

Mek'ele, Tigray, Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type BACKGROUND
PMID: 10219875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11461127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10580621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15866006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11486302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27795768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25358418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22434989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25164127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26609503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22510442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26788549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23332563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28503302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28212203 (View on PubMed)

Related Links

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https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/120215_SUR_SSI_2008-2009.pdf

Surveillance of surgical site infections in Europe, 2008-2009 by the European Centre for Disease Prevention and Control

http://www.ijpsr.info/docs/IJPSR15-06-10-013.pdf

Microbial contamination of operating theatre at Ayder Referral Hospital, Northern Ethiopia. International Journal of Pharma Sciences and Research, 6(10), 1264-1267

Other Identifiers

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2017-1251

Identifier Type: -

Identifier Source: org_study_id

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