Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

NCT05234515 | Completed

• 2 other identifiers: RD21/049301274
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Length of stay

  from day of surgery (day 0)

• Complications

  90 days

• Abdominal wound healing

  90 days

Study Arms (1)

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; Other: Questionnaire

Interventions

Microbiology swab DIAGNOSTIC_TEST

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.

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

Questionnaire OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults aged \>18 year
• Diagnosis of intestinal failure or enterocutaneous fistula
• Undergoing elective surgery within St Mark's hospital IF unit

You may not qualify if:

• Unable or unwilling to provide informed consent
• Pregnant

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

St Marks Hospital

Harrow, London, HA1 3UJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacterial culture

MeSH Terms

Conditions

Surgical Wound Infection; Intestinal Diseases; Intestinal Fistula

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Carolynne F Vaizey

  St Marks Hospital & Academic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: February 10, 2022
• Study Start: January 14, 2022
• Primary Completion: October 30, 2022
• Study Completion: February 20, 2023
• Last Updated: April 18, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)