Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery

Surgical Wound Infection Clinical Trial

— GlobalSurg 2  

Official title:

Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662231
• Other study ID #: GlobalSurg 2 Edinburgh
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: September 30, 2016

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Surgical site infection (SSI) is the most common complication following major gastrointestinal surgery, affecting between 25-40% of patients. The rate of SSI doubles from low-income to high-income settings, persisting after risk adjustment. Investigating the diagnosis and treatment of SSIs remains a largely unaddressed global health priority. The impact of antibiotic resistant organisms and the effectiveness of antibiotic prophylaxis are unknown. This study aims to determine SSI rates following gastrointestinal surgery across worldwide hospital settings.

Description:

The burden of surgically disease in low and middle-income countries (LMICs) is growing. Specific programmes have aimed to raise the profile of safe surgery and anaesthesia on the global health agenda. The Lancet Commission on Global Surgery have outlined six core indicators for the assessment of global surgical systems, including the postoperative mortality rate (POMR). Although mortality is the most extreme outcome of surgery, it only affects 1-4% of all patients. For major gastrointestinal surgery, efforts to quantify POMR alone neglect the associated morbidity, which is likely to affect a far greater proportion of patients [1]. More relevant markers of postoperative outcome are needed for the majority of patients, who will survive surgery.

Surgical site infection (SSI) is the most common complication following major gastrointestinal surgery, affecting between 25-40% of patients after midline laparotomy in high-income settings, and affects both adults and children. The effects of SSI can be life threatening. They are related to one-third of postoperative deaths and accounts for 8% of all deaths caused by a nosocomial infection. Furthermore, SSIs cause pain and discomfort, increasing the time taken to return home thus further amplifying the patient's potential nosocomial infection risk. This has an important economic impact. In the UK, hospital length of stay is doubled, with an attributable cost of £30 million per year.

The 2014 prospective, observational cohort study (GlobalSurg-1) included 10,475 patients from 58 countries. It showed that the incidence of SSI more than doubled from high (7.4%), to middle (14.4%), to low (20.0%) income countries. This persisted after multivariable risk adjustment for patient and hospital confounders (middle income: odds ratio 1.96 [1.63-2.32] and low income: 2.06 [1.67-2.57]). In the most contaminated and dirty operations, one in three patients from LMICs suffered an SSI. Dirty surgery doubled in low-income countries (29.7% versus 16.6% in high-income settings), which was in turn associated with doubling of SSI (34.5% low-income versus 15.4% high-income). However, SSI was assessed as a secondary outcome measure as part of that study, lacking validity and requiring external validation.

Antibiotic resistant organisms are now prevalent worldwide and a focus of interest for policy leaders and global health advocates. Some hospitals have no information on the rate of antibiotic resistant SSIs. For those patients who contract infections caused by resistant organisms, they are posed with a higher risk of mortality, morbidity and require more healthcare resources. Currently no data exists to describe the international epidemiology of SSIs, their causative organisms and drug-resistance. Therefore, investigating the diagnosis and treatment of SSIs is an urgent global health priority.

The primary aim of this study is to determine SSI rates across low, middle and high Human Development Index (HDI) countries. The secondary aims include describing organisms causing SSI rates, use of microbiologic tests, and rate of antibiotic resistant SSI. The impact of the method of 30-day follow-up on these outcomes will also be analysed. Other aims include describing the burden of surgical disease using 30-day mortality rates, perforated appendicitis rates and laparoscopic cholecystectomy rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12539
• Est. completion date: September 30, 2016
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Centre Inclusion Criteria:

• Any surgical unit worldwide is eligible to enter

• All participating centres will be required to register their details, complete an online training module, and complete a pilot audit prior to commencing

• Centres must ensure that they can include consecutive patients and provide at least 95% data completeness

• There is no minimum number of patients per centre, as long as the patient(s) included are consecutive

Inclusion criteria:

• Patients of all ages (adult and paediatric)

• Consecutive patients during a chosen 14-day study period

• Undergoing emergency or elective gastrointestinal resection, cholecystectomy and appendectomy.

• Includes open, laparoscopic, laparoscopic converted and robotic cases

• Primary indication of trauma should be included

• Hernia repair with bowel resection should be included

Exclusion criteria:

• Operations with a primary indication that is vascular, gynaecological, urological (including ileal conduit) or transplant

• Caesarean sections

• Whipples procedure

• Simple hernia repair

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• Emergency, or elective gastrointestinal resection
Gastrointestinal resection is defined as complete transection and removal of a segment of the oesophagus, stomach, small bowel, colon or rectum, including cholecystectomy, and appendicectomy.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (12)

Bhangu A, Fitzgerald JE, Fergusson S, Khatri C, Holmer H, Soreide K, Harrison EM. Determining universal processes related to best outcome in emergency abdominal surgery: a multicentre, international, prospective cohort study. BMJ Open. 2014 Oct 29;4(10):e006239. doi: 10.1136/bmjopen-2014-006239. — View Citation

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. — View Citation

Earnshaw S, Mendez A, Monnet DL, Hicks L, Cruickshank M, Weekes L, Njoo H, Ross S. Global collaboration to encourage prudent antibiotic use. Lancet Infect Dis. 2013 Dec;13(12):1003-4. doi: 10.1016/S1473-3099(13)70315-3. Epub 2013 Nov 17. No abstract available. — View Citation

Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available. Erratum In: Am J Infect Control. 2008 Nov;36(9):655. — View Citation

Laxminarayan R, Duse A, Wattal C, Zaidi AK, Wertheim HF, Sumpradit N, Vlieghe E, Hara GL, Gould IM, Goossens H, Greko C, So AD, Bigdeli M, Tomson G, Woodhouse W, Ombaka E, Peralta AQ, Qamar FN, Mir F, Kariuki S, Bhutta ZA, Coates A, Bergstrom R, Wright GD, Brown ED, Cars O. Antibiotic resistance-the need for global solutions. Lancet Infect Dis. 2013 Dec;13(12):1057-98. doi: 10.1016/S1473-3099(13)70318-9. Epub 2013 Nov 17. Erratum In: Lancet Infect Dis. 2014 Jan;14(1):11. Lancet Infect Dis. 2014 Mar;14(3):182. — View Citation

Meara JG, Greenberg SL. The Lancet Commission on Global Surgery Global surgery 2030: Evidence and solutions for achieving health, welfare and economic development. Surgery. 2015 May;157(5):834-5. doi: 10.1016/j.surg.2015.02.009. No abstract available. — View Citation

Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9. — View Citation

Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D; West Midlands Research Collaborative; ROSSINI Trial Investigators. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ. 2013 Jul 31;347:f4305. doi: 10.1136/bmj.f4305. — View Citation

Plowman R, Graves N, Griffin MA, Roberts JA, Swan AV, Cookson B, Taylor L. The rate and cost of hospital-acquired infections occurring in patients admitted to selected specialties of a district general hospital in England and the national burden imposed. J Hosp Infect. 2001 Mar;47(3):198-209. doi: 10.1053/jhin.2000.0881. — View Citation

Smyth ET, McIlvenny G, Enstone JE, Emmerson AM, Humphreys H, Fitzpatrick F, Davies E, Newcombe RG, Spencer RC; Hospital Infection Society Prevalence Survey Steering Group. Four country healthcare associated infection prevalence survey 2006: overview of the results. J Hosp Infect. 2008 Jul;69(3):230-48. doi: 10.1016/j.jhin.2008.04.020. Epub 2008 Jun 11. — View Citation

Tanner J, Khan D, Aplin C, Ball J, Thomas M, Bankart J. Post-discharge surveillance to identify colorectal surgical site infection rates and related costs. J Hosp Infect. 2009 Jul;72(3):243-50. doi: 10.1016/j.jhin.2009.03.021. Epub 2009 May 15. — View Citation

Wilson AP, Gibbons C, Reeves BC, Hodgson B, Liu M, Plummer D, Krukowski ZH, Bruce J, Wilson J, Pearson A. Surgical wound infection as a performance indicator: agreement of common definitions of wound infection in 4773 patients. BMJ. 2004 Sep 25;329(7468):720. doi: 10.1136/bmj.38232.646227.DE. Epub 2004 Sep 14. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Follow up method for detecting surgical site infection	Assessing method used to detect SSI at thirty day review (i.e. still an inpatient, clinic review, telephone review, community/home review, discharged before 30 days and not contacted again)	Within 30 days of surgery
Other	Complicated appendicitis rate	Includes radiological or clinical perforation of the appendix, empyema or abscess formation, and fecal peritonitis.	Pre-, or intra-operatively
Other	Laparoscopic cholecystectomy rate		Intra-operatively
Primary	Superficial incisional surgical site infection (SSI)	This measure adapts the definitions within the 2008 Centre for Disease Control definitions of SSI.	Within 30 days of surgery
Secondary	Postoperative mortality rate (POMR)	Death any time after skin incision until the 30th day after surgery. If the patient is discharged alive but not seen again by day 30, this is equivalent to the in-patient mortality rate.	Within 30 days of surgery
Secondary	Postoperative re-intervention rate	Operative, radiological or endoscopic re-intervention any time after skin incision until the 30th day after surgery. If the patient is discharged alive but not seen again by day 30, this is equivalent to the inpatient re-intervention rate.	Within 30 days of surgery
Secondary	Rate of antibiotic-resistant surgical site infection	Describing international variation, where available.	Within 30 days of surgery
Secondary	Organism causing surgical site infection	Patient-level, online questionnaire. Organisms identified upon microscopy and culture. Grouped by recognised causative bacteria in superficial surgical site infection (i.e. Staphylococcus Aureus, Coliform, Anaerobe, Other)	Within 30 days of surgery
Secondary	Proportion of patients treated in a hospital with microscopy, culture and sensitivity testing	Patient-level, online questionnaire.	Within 30 days of surgery

External Links

•   GlobalSurg-II Project Hub