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Surgical Wound InfectionNCT03761459

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

An observational study of Surgical Wound Infection and Infected Wound, run by University of Illinois Chicago at 1 site in Ethiopia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,240 participants
Where
1 siteEthiopia
Study dates
20 Mar 2018to 30 Dec 2023
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

  • Ayder Comprehensive Referral Hospital

    Mek'ele, Tigray

Other trials in Ethiopia

About this study

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.

Read the 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.

Keywords
Surgical site infection, low and middle income country, low resource setting, Africa, Ethiopia
Medical subject headings
Surgical Wound Infection, Wound Infection, Surgical Wound

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (2)

  1. Surgical site infection incidence at ACSH

    Determine the current surgical site infection rate at ACSH through prospective data collection of operations occurring at ACSH during the study period

    Measured: 30 days from operation

  2. Trends between adherence to WHO SUSP guidelines and infection

    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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start20 Mar 2018
  3. Primary completion8 Oct 2019
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,240 participants (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03761459
Sponsor's protocol ID
2017-1251
Status last verified
May 2023
First submitted
29 Nov 2018
Last updated
8 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be available to anyone outside of our study.

Publications

  • 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.

    PubMed 10219875

  • 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.

    PubMed 11461127

  • 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.

    PubMed 10580621

  • 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.

    PubMed 15866006

  • 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.

    PubMed 11486302

  • 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.

    PubMed 27795768

  • 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.

    PubMed 25358418

  • 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.

    PubMed 22434989

  • 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.

    PubMed 25164127

  • 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.

    PubMed 26609503

  • 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.

    PubMed 22510442

  • 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.

    PubMed 26788549

  • 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.

    PubMed 23332563

  • 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.

    PubMed 28503302

  • 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.

    PubMed 28212203

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Wound Infection and Infected Wound, run by University of Illinois Chicago at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to World Health Organization (WHO) Surgical Unit based Safety Programme (SUSP) guidelines (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03761459, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.

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