Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

Completed

• Conditions: Surgical Site Infection; Surgical Wound Infection; Bacteria Infection Mechanism; Intestinal Disease; Intestinal Fistula
• Interventions: Diagnostic Test: Microbiology swab; Other: Questionnaire

• Registration Number: NCT05234515
• Lead Sponsor: London North West Healthcare NHS Trust

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-28
• Study Start: 2022-01-14
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-10
• Status Verified: 2022-10
• Primary Completion: 2022-10-30
• Study Completion: 2023-02-20
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery.	Microbiology swab	Adult patients with a diagnosis of intestinal failure (IF) or an enterocutaneous fistula (ECF) undergoing planned surgery in our unit.
Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery.	Questionnaire	Adult patients with a diagnosis of intestinal failure (IF) or an enterocutaneous fistula (ECF) undergoing planned surgery in our unit.

Primary Outcome Measures

Name	Time	Method
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
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)
Microbiological	0-90 days	Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples
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)
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)
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)

Secondary Outcome Measures

Name	Time	Method
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'

Trial Locations

Locations (1)

St Marks Hospital; 🇬🇧 Harrow, London, United Kingdom