Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

Surgical Site Infection Clinical Trial

— BUGS-IN-IF  

Official title:

Prospective Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234515
• Other study ID #: RD21/049
• Secondary ID: 301274
• Status: Completed
• Start date: January 14, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: October 2022
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 20, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteria Infection Mechanism
• Communicable Diseases
• Fistula
• Infections
• Intestinal Disease
• Intestinal Diseases
• Intestinal Fistula
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	St Marks Hospital	Harrow	London

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Microbiological	Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples	0-90 days
Primary	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
Primary	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
Primary	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
Primary	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	Length of stay	Duration of index hospital admission, measured in days	from day of surgery (day 0)
Secondary	Complications	Classified using the Clavien-Dindo classification(I-V)	90 days
Secondary	Abdominal wound healing	Classified as either 'completely healed' OR 'incompletely healed'	90 days