BUGS-IN-IF: Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

Sponsor

London North West Healthcare NHS Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT05234515

Collaborator

(none)

Enrollment

Location

4.5

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Infection Surgical Site Infection Bacteria Infection Mechanism Intestinal Disease Intestinal Fistula	Diagnostic Test: Microbiology swab Other: Questionnaire

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

Actual Study Start Date :

Jan 14, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery. Adult patients with a diagnosis of intestinal failure (IF) or an enterocutaneous fistula (ECF) undergoing planned surgery in our unit.	Diagnostic Test: Microbiology swab 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. Other: Questionnaire 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.

Arm

Intervention/Treatment

Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery.

Adult patients with a diagnosis of intestinal failure (IF) or an enterocutaneous fistula (ECF) undergoing planned surgery in our unit.

Diagnostic Test: Microbiology swab

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.

Other: Questionnaire

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.

Outcome Measures

Primary Outcome Measures

Clinical Surgical Site Infection (SSI) [0-90 days]
Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021
Microbiological [0-90 days]
Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples
Change in Generic Quality of Life Score [Baseline - 90 days]
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)
Change in Wound Specific Quality of Life Score [Baseline - 90 days]
Quantified by the Wound-QoL questionnaire, a validated 17 item scale at baseline, 30 and 90 days (Minimum score 0, Maximum score 68)
Decision conflict [Day 0]
Preoperative decision conflict scores quantified by decision conflict scale (DCS), a validated 16 point scale (Minimum score 0, Maximum score 64)
Change in Decision Regret [30 and 90 days]
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)

Secondary Outcome Measures

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