An observational study in Surgical Wound Infection, Surgical Site Infection and Bacteria Infection Mechanism, sponsored by London North West Healthcare NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by London North West Healthcare NHS Trust · Observational
Among 21 studies in Surgical Wound Infection with a site in United Kingdom — 2 open to participants now, 2 under way, 1 of them phase 3. Surgical Wound Infection · United Kingdom.
Among the 21 studies in Surgical Wound Infection with a site in United Kingdom, this one is one of 2 that started in 2022, is one of 8 observational ones, and was the 18th registered.
746 studies on the registry are indexed under Surgical Wound Infection; 152 are open to participants now.
Browse Surgical Wound Infection studies →2 of the 21 studies in Surgical Wound Infection with a site in United Kingdom are open now. Recruiting first, the newest first:
Guy's and St Thomas' NHS Foundation Trust · Sites in United Kingdom
Ages 16+
East Lancashire Hospitals NHS Trust · Sites in United Kingdom
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 84 Surgical Wound Infection studies recruiting now, 60 (71%) set no upper age limit and 16 (19%) stop at 75 or younger; 12 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2022.
This study's enrollment of 21 is below the median of 239 across 135 observational studies indexed under Surgical Wound Infection.
Median enrollment 211 across the 13 interventional studies, 2,552 across the 8 observational. Of the 15 that completed or were terminated, 2 (13%) have results posted.
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1 of 21 have an industry lead sponsor. The 10 most frequent:
London North West Healthcare NHS Trust is the lead sponsor of 55 studies on the registry; 10 are open to participants now.
London North West Healthcare NHS Trust has 1 study filed under Surgical Wound Infection — fewer than ten, so there is no comparison to draw.
1 of the studies in Surgical Wound Infection with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05964140Phase 3East Lancashire Hospitals NHS TrustThe MANTRA Trial (MANdibular TRauma and Antibiotic Use) | 2027-06-30 |
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Among the 21 studies in Surgical Wound Infection with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are:
Patients will be recruited from the intestinal failure unit at St Mark's hospital, London North West University Healthcare NHS Trust.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with a diagnosis of intestinal failure (IF) or an enterocutaneous fistula (ECF) undergoing planned surgery in our unit.
Diagnostic Test: Microbiology swab · Other: Questionnaire
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.
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.
Clinical Surgical Site Infection (SSI)
Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021
Time frame: 0-90 days
Microbiological
Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 30 and 90 days
Length of stay
Duration of index hospital admission, measured in days
Time frame: from day of surgery (day 0)
Complications
Classified using the Clavien-Dindo classification(I-V)
Time frame: 90 days
Abdominal wound healing
Classified as either 'completely healed' OR 'incompletely healed'
Time frame: 90 days
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Oct 2022, 9 months.
Of 65 non-industry observational studies under Surgical Wound Infection, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 53. This study's 9 months is below that.
Counting every sponsor, half of 68 studies reached it within 21 months; a quarter within 9 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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London North West Healthcare NHS Trust