Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

Study Overview
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Brief Summary
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This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are: To prospectively characterise preoperative bacterial populations amongst patients undergoing surgery for intestinal failure To examine the relationship between preoperative bacteriology and surgical site infection (SSI) in this patient group To investigate the effect of surgery and surgical site infection on generic and wound specific quality of life measures

Official Title
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Prospective Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

Conditions
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Surgical Wound Infection, Surgical Site Infection, Bacteria Infection Mechanism, Intestinal Disease, Intestinal Fistula

Intervention / Treatment
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* Diagnostic Test: Microbiology swab
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged >18 year Diagnosis of intestinal failure or enterocutaneous fistula Undergoing elective surgery within St Mark's hospital IF unit Exclusion Criteria: Unable or unwilling to provide informed consent Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery.<br>Adult patients with a diagnosis of intestinal failure (IF) or an enterocutaneous fistula (ECF) undergoing planned surgery in our unit. | Diagnostic Test: Microbiology swab<br>* Patients will have swabs taken from the nose, mouth, umbilical skin, groin skin, fistula(e), stoma(s) and vascular access device prior to surgery. Patients will be followed for 90 days postoperatively for surgical site infection (SSI) as defined by the centre for disease control (CDC) criteria 2021. Patients who develop an SSI will have both preoperative and postoperative samples sent for genome sequencing.<br>Other: Questionnaire<br>* Patients will complete baseline preoperative questionnaires which will be repeated at 30 days and 90 days. These will evaluate generic and wound specific quality of life as well as decision conflict/decision regret.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Surgical Site Infection (SSI) | Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021 | 0-90 days | 
| Microbiological | Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples | 0-90 days | 
| Change in Generic Quality of Life Score | Generic health scores quantified by the validated EuroQoL 5 dimension, 5 level questionnaire (EQ5D-5L) at baseline, 30 and 90 days. (Minimum score 5, Maximum score 25) | Baseline - 90 days | 
| Change in Wound Specific Quality of Life Score | Quantified by the Wound-QoL questionnaire, a validated 17 item scale at baseline, 30 and 90 days (Minimum score 0, Maximum score 68) | Baseline - 90 days | 
| Decision conflict | Preoperative decision conflict scores quantified by decision conflict scale (DCS), a validated 16 point scale (Minimum score 0, Maximum score 64) | Day 0 | 
| Change in Decision Regret | Postoperative decision regret scores quantified by the decision regret scale (DRS) a validated 5 item questionnaire, at 30 and 90 days. (Minimum score 5, Maximum score 25) | 30 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Duration of index hospital admission, measured in days | from day of surgery (day 0) | 
| Complications | Classified using the Clavien-Dindo classification(I-V) | 90 days | 
| Abdominal wound healing | Classified as either 'completely healed' OR 'incompletely healed' | 90 days |