Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

NCT05234515 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2023-04-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • London North West Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Carolynne F Vaizey · St Marks Hospital & Academic Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2022-10-30
Completion
2023-02-20

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234515 on ClinicalTrials.gov