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NCT Number: NCT05234515

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

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Key information

Conditions

Surgical Wound Infection Bacteria Infection Mechanism Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Infections Intestinal Disease Intestinal Diseases Intestinal Fistula Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Marks Hospital

Harrow, London, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Clinical Surgical Site Infection (SSI)

    Time frame: 0-90 days

    Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021

  2. Microbiological

    Time frame: 0-90 days

    Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples

  3. Change in Generic Quality of Life Score

    Time frame: 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)

  4. Change in Wound Specific Quality of Life Score

    Time frame: 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)

  5. Decision conflict

    Time frame: Day 0

    Preoperative decision conflict scores quantified by decision conflict scale (DCS), a validated 16 point scale (Minimum score 0, Maximum score 64)

  6. Change in Decision Regret

    Time frame: 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)

Secondary outcomes

  1. Length of stay

    Time frame: from day of surgery (day 0)

    Duration of index hospital admission, measured in days

  2. Complications

    Time frame: 90 days

    Classified using the Clavien-Dindo classification(I-V)

  3. Abdominal wound healing

    Time frame: 90 days

    Classified as either 'completely healed' OR 'incompletely healed'

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study title

Prospective Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

Acronym: BUGS-IN-IF

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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