An SSI is defined as a wound infection occurring at the site of a surgical incision. It is a major potential complication of any operation, ranging from minor superficial wound infection to deep infection , . Despite NICE recognising SSI as a leading cause of in-hospital morbidity and mortality, incidence remains high , .
The groin is the most common site for an incision in vascular surgery , , used to provide access to the femoral vessels. Predisposition to infection is due to the several co-morbidities that vascular patients typically have , , , the type of skin flora which reside in the groin, difficulties in decontaminating the area of skin commensals and its proximity to the anal canal and genitalia , , . The incidence of SSIs following groin incision has been reported as up to 27% , with the highest risk associated with groin incisions for bypass surgery . Re-do groin surgery is associated with even greater risk of SSI and subsequent morbidity and mortality , . Authors have developed risk scoring tools to identify vascular patients at risk of developing SSIs , . However, their value in predicting SSIs relating specifically to groin surgery is not known.
VERN was founded in 2014 and is the official vascular trainee research collaborative of the United Kingdom . Its multidisciplinary structure fosters close links between trainee surgeons, nurses and vascular scientists on a national basis. VERN has successfully delivered several multi-centre audits without incurring cost using this collaborative approach , , .
To compare the performance of the local vascular unit against UK NICE guidance relating to SSIs (supplementary material 1) in the groin incisions of vascular patients.
An international, multicentre audit of practice, and a prospective observational cohort study disseminated via VERN.
Hospitals providing emergency and/or elective vascular surgery in the UK and abroad, recruited via VERN. Based on current interest it is expected at least 25 centres will be enrolled.
The GIVE audit was officially launched on 21st January 2019. The UK will close to new participating centres on 1st May 2019. Centres are encouraged to start data collection as soon as possible once appropriately registered. Data from consecutive groin incisions meeting the inclusion criteria will be collected prospectively for 3 months.
Follow up data will be captured at 90 days following surgery. The entire study period will span 6 months. Centres are required to return all data within 7 months of starting, which will allow 1 month from last data point for all data capture.
The audit will enrol consecutive patients undergoing a groin incision for access to the femoral arteries.
The local study team will be responsible for contemporaneous data collection. Theatre information technology systems will be used to screen for eligible patients regularly. Datapoints consisting of key demographic, baseline variables and intra-operative variables will be collected as early as possible following surgery. Post-operative sequelae datapoints will be preferentially collected as soon as the 90-day follow up threshold is reached. Should an SSI develop, further details will be required about the extent of the infection and resultant patient outcome. Data capture tools were drafted and refined to ensure appropriate data points will be captured (supplementary material 2).
Data will be obtained using patient’s notes and electronic records – including pre-operative assessment documentation, theatre information technology systems, discharge letters, clinic letters and accident and emergency department records. No changes to normal patient follow up will be made, and the patient will not be contacted to enquire about SSIs, unless this encompasses centre specific standard care.
Data will be recorded on an anonymised online data collection tool or held electronically locally, and anonymous data transferred to the GIVE Audit team via secure encrypted email. No patient identifiable information will be transferred from participating centres. Patients will be pseudoanonymised at each participating centre. The local audit lead will organise for the local centre to hold a secure database with a minimum of three patient identifiers (e.g name/hospital number/date of birth) and a 3 digit pseudoanonymised number. The pseudoanonymised number will be used to link peri-operative data and 90-day post-operative outcome data.
Data will be collated, stored and analysed by the GIVE Audit team at the Royal Gwent Hospital, Aneurin Bevan University Health Board, Newport, UK.
The primary outcome will be compliance with NICE guidelines on SSI prevention.
An SSI will be defined as per the Centres for Disease Control and Prevention (CDC) criteria (supplementary material 3) . These guidelines state that superficial SSIs are those presenting within 30 days of surgery, whilst deep or organ/space SSIs are those presenting within 90 days.
SSIs will be limited to those apparent to the treating vascular team within 90 days of surgery. It is recognised that this study may therefore fail to capture milder infections which are treated in the community.
Secondary outcomes include (all for up to 90 days):
AKI will be defined according to the Acute Kidney Injury Network (AKIN) criteria (supplementary material 4) .
Sepsis will be defined according to a definition recommended by the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) (supplementary material 5) .
A groin incision can be extended inferiorly (e.g. for vein harvest), or superiorly onto the abdomen (e.g. for iliac vessel exposure). In these instances, the groin incision will be considered as that which overlies the femoral triangle. SSIs distant to the groin, such as in the mid-thigh, will not be captured. In cases of uncertainty, the decision of the overseeing consultant will be sought.
In the event of both groins being used simultaneously, data on each incision will be captured separately. If both groins of a patient are used sequentially (at different dates, but both within the audit timeframe) they will also be captured separately.
Should a patient already enrolled onto the GIVE audit return to theatre and require re-opening of the index groin incision for a reason other than SSI (e.g. for repair of a pseudoaneurysm arising from the original surgery), this would not be captured as a new groin incision, but rather as a return to theatre.
Data completeness is considered essential. Data points recorded as ‘unknown’, where this option is available, will count as complete data. Cases with <95% of data completeness will be returned to the participating centre for completion, or if this is impossible, will be excluded from analysis, as is standard with international collaborative audits , .
Certain centres will be asked to review a small number of patient data points (approximately 5%) to confirm case ascertainment and data accuracy, as is standard with international collaborative audits , . This will comprise of a review of the data collection by an individual not involved with its initial collection.
Analyses will be performed to assess overall SSI rates and examine secondary outcomes. Data will be checked for normality and the appropriate parametric or non-parametric test used. Individual unit SSI rates will be presented in funnel plot form, with lines representing ±2 and ±3 standard deviations. Individual unit rates will not be identified. Univariate and multivariate regression analyses will be used to identify significant variables predictive of SSIs. Variables reaching threshold of p < 0.10 on univariate analysis will be put forward to the multivariate regression analysis. P < 0.05 will be used to define statistical significance.
Two published risk prediction tools will be evaluated to assess their accuracy in predicting SSIs in this cohort (supplementary material 6) , . A receiver operating characteristic (ROC) curve will be plotted for each tool, with calculation of area under the curve (AUC) as the summary statistic.
The GIVE audit is open to all centres that provide an elective and/or emergency arterial vascular service. UK vascular units often comprise of a Hub and Spoke type model. A registered Hub site may be able to undertake data collection for Spoke sites, depending on practicalities and local policies, without registering the Spoke site separately. However, it is noted that the majority of arterial operations will be performed at the Hub site therefore data collection from Spoke sites is likely to be minimal.
Each centre will require the support of a supervising consultant, and a data collection team. The supporting consultant is expected to facilitate audit registration/ethical approval, provide unit support for engagement with the GIVE study, act as a guarantor to data capture and upload/transfer, provide workplace-based assessments documentation for team members, and facilitate local presentation of the audit results at an appropriate local meeting.
Decision-making tools provided by the NHS Health Research Authority (HRA) (“Is My Study Research?”  and “Do I need NHS Research Ethics Committee (REC) approval?” ) were used to determine that this study does not require approval from an NHS Research Ethics Committee.
The GIVE audit is required to be registered in each participating centre prospectively, prior to data collection. Participating centres that are situated outside of the UK will need to comply with local regulations prior to commencing, which may require prospective approval from an ethics committee. The agreement of a consultant vascular surgeon (or equivalent for non-UK centres) is required to oversee the process.
The GIVE Audit received Caldicott Guardian approval from the corresponding author’s institution to store pseudoanonymised data on secure NHS computers, and undertake appropriate statistical analysis.
Data will be submitted for presentation at national and international meetings. A paper, or papers of the resultant data will be submitted for peer-reviewed publication. A writing team, including those involved with the design, implementation and dissemination of the GIVE audit, and those contributing to data analysis in the cohort study will be responsible for both presentation(s) and publication(s). For both presentation(s) and publication(s) a collaborative authorship model will be used. To qualify for PubMed-citable collaborative co-authorship individuals must have either:
It is encouraged that data for each centre is presented locally. Summary data for each participating site will be provided to the local audit leads, with comparisons to the group average.
This multicentre, international audit and observational cohort study will allow us to reliably determine the incidence and burden of groin SSI in this cohort. The strengths of the GIVE audit will lie in its use of contemporaneous data collection from numerous hospitals around the UK and internationally.
Compared to existing audits of vascular SSI, the protocol is designed to collect information in greater depth, due to the focus on vascular groin incisions. Previous studies have been limited by the variety of tools used to classify SSI. This audit will include the most recent CDC definition of SSI, and longer term follow up than recent audits. This will permit more information to be gathered on patient, surgical and theatre factors.
It is anticipated that the cohort study will provide impactful data for future comparisons with global practice and support the design of robust and meaningful studies. By including criteria for two published SSI prediction tools, we will be able to assess if either tool accurately predicts SSIs in this cohort. The large number of sites included will identify areas of significant variation in practice, suggesting clinical equipoise.
Limitations of the observational cohort study will include its inability to define specific causative associations between factors and incidence of SSI. Therefore, focus will be placed on factors either known to contribute to SSI, or areas with limited evidence base. Although the VERN collaborative has experience of data collection from previous studies, it will be impossible to confirm reliable consecutive patient recruitment. Finally, the data will be limited to clinically relevant SSIs that are severe enough to prompt review or referral to secondary care.
Snapshot audits of this nature have been shown to collect robust and useful data to guide national guidelines and surgical research priorities, especially in the setting of SSIs in other specialties such as colorectal surgery , . Expanding surgical audits internationally has permitted the development of research links between high, middle- and low-income countries , , and we anticipate that success of the GIVE audit will support further collaboration with trainees globally, supporting the global surgery agenda and promoting good surgical practice with colleagues around the world.
Decision-making tools provided by the NHS Health Research Authority (HRA) (“Is My Study Research?” and “Do I need NHS Research Ethics Committee (REC) approval?”) were used to determine that this study does not require approval from an NHS Research Ethics Committee.
The GIVE Audit received Caldicott Guardian approval from the corresponding author’s institution to store pseudoanonymised data on secure NHS computers, and undertake appropriate statistical analysis.
Conception or design of work: AS RB RF GD ND TL JS DCB.
Contributed to data or analysis tools: BLG AS RB RF GD ND TL JS DCB.
Manuscript writing: BLG AS RB RF GD ND TL RP JS DCB.
Critical revision of the manuscript: BLG AS RB RF GD ND TL RP JS DCB.
Final approval of the version to be published: BLG AS RB RF GD ND TL RP JS DCB.
No conflicts of interest to declare.
Brenig Gwilym and David Bosanquet.
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Supplementary data to this article can be found online at https://s3-eu-west-1.amazonaws.com/ubiquity-partner-network/ijs/journal/ijsp/IJSP38.zip.