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

Prospective Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

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 Overview

• Status: Completed
• Conditions: Surgical Wound Infection; Intestinal Fistula; Surgical Site Infection; Intestinal Disease; Bacteria Infection Mechanism
• Intervention / Treatment: Diagnostic test: Microbiology swab; Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United Kingdom
  • London
    • Harrow, London, United Kingdom, HA1 3UJ
      • St Marks Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients will be recruited from the intestinal failure unit at St Mark's hospital, London North West University Healthcare NHS Trust.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: London North West Healthcare NHS Trust
• Investigators: Principal Investigator: Carolynne F Vaizey, St Marks Hospital & Academic Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Wounds and Injuries; Disease Attributes; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Digestive System Fistula; Infections; Communicable Diseases; Fistula; Intestinal Diseases; Surgical Wound; Surgical Wound Infection; Wound Infection; Intestinal Fistula
• Other Study ID Numbers: RD21/049; 301274 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared. Summary findings will be disseminated to other health care workers and patient groups at conference where the work will be presented. The data will be submitted to a peer-reviewed medical journal for publication. Internal reports will update on the progress of the work. The data will be under the ownership of London north west university healthcares trust (LNWUHT). The PhD student involved, and their team will have rights to publish the data. Patient participants will be notified of publications and asked if they would like to receive copies following the study period.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No