Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

London North West Healthcare NHS Trust21 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

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.

QuestionnaireOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical Surgical Site Infection (SSI)

Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021

Time frame: 0-90 days

Microbiological

Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 30 and 90 days

Secondary Outcomes

Length of stay

Duration of index hospital admission, measured in days

Time frame: from day of surgery (day 0)

Complications

Classified using the Clavien-Dindo classification(I-V)

Time frame: 90 days

Abdominal wound healing

Classified as either 'completely healed' OR 'incompletely healed'