Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure
NCT ID: NCT05234515
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
21 participants
OBSERVATIONAL
2022-01-14
2023-02-20
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of intestinal failure or enterocutaneous fistula
* Undergoing elective surgery within St Mark's hospital IF unit
Exclusion Criteria
* Pregnant
18 Years
ALL
No
Sponsors
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London North West Healthcare NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Carolynne F Vaizey
Role: PRINCIPAL_INVESTIGATOR
St Marks Hospital & Academic Institute
Locations
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St Marks Hospital
Harrow, London, United Kingdom
Countries
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Other Identifiers
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301274
Identifier Type: OTHER
Identifier Source: secondary_id
RD21/049
Identifier Type: -
Identifier Source: org_study_id
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