Surgical Wound InfectionBUGS-IN-IFNCT05234515
Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure
An observational study of Surgical Wound Infection and Surgical Site Infection, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection, Surgical Site Infection, Bacteria Infection Mechanism
- What is being tested?
- Microbiology swab and Questionnaire
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2022to 20 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the intestinal failure unit at St Mark's hospital, London North West University Healthcare NHS Trust.
Who may be able to join
- Adults aged >18 year
- Diagnosis of intestinal failure or enterocutaneous fistula
- Undergoing elective surgery within St Mark's hospital IF unit
Who cannot join
- Unable or unwilling to provide informed consent
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective 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
- Conditions
- Surgical Wound Infection, Surgical Site Infection, Bacteria Infection Mechanism, Intestinal Disease, Intestinal Fistula
- Being tested
- Microbiology swab, Questionnaire
- Medical subject headings
- Surgical Wound Infection, Intestinal Diseases, Intestinal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiology swabDiagnostic 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.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Microbiology swab; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Surgical Site Infection (SSI)
Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021
Measured: 0-90 days
Microbiological
Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 30 and 90 days
Secondary outcomes (3)
Length of stay
Duration of index hospital admission, measured in days
Measured: from day of surgery (day 0)
Complications
Classified using the Clavien-Dindo classification(I-V)
Measured: 90 days
Abdominal wound healing
Classified as either 'completely healed' OR 'incompletely healed'
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start14 Jan 2022
- Primary completion30 Oct 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolynne F Vaizey, Principal investigator, St Marks Hospital & Academic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234515
- Sponsor's protocol ID
- RD21/049
- Other IDs
- 301274
- Acronym
- BUGS-IN-IF
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. Summary findings will be disseminated to other health care workers and patient groups at conference where the work will be presented. The data will be submitted to a peer-reviewed medical journal for publication. Internal reports will update on the progress of the work. The data will be under the ownership of London north west university healthcares trust (LNWUHT). The PhD student involved, and their team will have rights to publish the data. Patient participants will be notified of publications and asked if they would like to receive copies following the study period.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure
- ClinicalTrials.gov ID
- NCT05234515
- Acronym / sponsor ID
- BUGS-IN-IF / RD21/049
- Conditions
- Surgical Wound Infection, Surgical Site Infection, Bacteria Infection Mechanism, Intestinal Disease, Intestinal Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery. | – | Diagnostic Test: Microbiology swab, Other: QuestionnaireAdult patients with a diagnosis of intestinal failure (IF) or an enterocutaneous fistula (ECF) undergoing planned surgery in our unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the intestinal failure unit at St Mark's hospital, London North West University Healthcare NHS Trust.
Key inclusion criteria (3 listed)
- Adults aged >18 year
- Diagnosis of intestinal failure or enterocutaneous fistula
- Undergoing elective surgery within St Mark's hospital IF unit
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiology swabPatients 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. | Diagnostic test | Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery. |
| QuestionnairePatients 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. | Other | Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery. |
Primary outcome
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
Microbiological
Time frame: 0-90 days
Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples
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)
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)
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)
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)
3 secondary outcomes
Length of stay
Time frame: from day of surgery (day 0)
Complications
Time frame: 90 days
Abdominal wound healing
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. No IPD will be shared. Summary findings will be disseminated to other health care workers and patient groups at conference where the work will be presented. The data will be submitted to a peer-reviewed medical journal for publication. Internal reports will update on the progress of the work. The data will be under the ownership of London north west university healthcares trust (LNWUHT). The PhD student involved, and their team will have rights to publish the data. Patient participants will be notified of publications and asked if they would like to receive copies following the study period.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolynne F Vaizey principal investigator
St Marks Hospital & Academic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Infection and Surgical Site Infection, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Surgical Site Infection (SSI) (time frame: 0-90 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.