Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05513677 |
| Other study ID # |
PRO30CSP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 14, 2018 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
August 2022 |
| Source |
Camstent Ltd. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
1. Evaluated Patients: 5 patients (Convenience sample: non-blinded, non-randomised)
Selection follows documented hospital protocols for routine catheterisation
2. Measured Patients: 30 patients (Convenience sample: non-blinded and non-randomised)
- 20 who receive the M4D coated catheter.
- 10 who receive the standard uncoated catheters used in routine patient care.
Description:
1. Evaluated Patients: 5 patients (Convenience sample: non-blinded, non-randomised)
Selection follows documented hospital protocols for routine catheterisation
2. Measured Patients: 30 patients (Convenience sample: non-blinded and non-randomised)
- 20 who receive the M4D coated catheter.
- 10 who receive the standard uncoated catheters used in routine patient care.
1) Evaluation (5 patients, coated catheter)
A convenience sample of patients will be selected to receive the Camstent coated catheter for
their routine care. These enrolments are drawn from among those recommended for routine
catheterisation, for up to 28 days and in accordance to existing hospital protocols. There is
no change to the routine protocols for insertion, maintenance, withdrawal, or documentation
of the patient's catheterisation. Following use, the catheter is discarded according to the
hospital's procedures.
Staff questionnaires will be completed to capture general use information. These will
document the opinions of the nurse inserting and withdrawing the catheter, and may include
questions for the patient, to record their experience. There will be no collection of patient
information, and no analysis of the discarded catheter.
2) Measurement (10 patients receiving uncoated catheters, 20 patients receiving coated
catheters)
The data collection will include 10 patients who have received the standard hospital issued
uncoated catheter and 20 patients who have received the Camstent coated catheter. There will
be no randomisation and no blinding.
The first 10 patients needing routine urinary catheterisation to drain their bladder for up
to 28 days whilst in hospital will receive the routine hospital issued catheter and will
looked after by hospital and staff as standard practice.
The next 20 patients needing routine urinary catheterisation to drain their bladder whilst in
hospital will receive a coated catheter. There will be no change to the intended use of the
catheter for patients where it is deemed medically necessary to drain urine from the urinary
bladder via the urethra using the catheter device for up to 28 days. There will be no change
to any patient care or catheterisation procedures.
All 30 catheters will be sent to a laboratory for surface examination rather than immediately
disposed of as medical waste. Harvested catheters will be bagged in an airtight plastic bag
and tagged with a record identifier. A record identifier will be used to establish catheter
traceability and duration, and will not compromise patient anonymity. The catheter will be
kept refrigerated and transported to the analysis laboratory at Nottingham University within
two days.
At the Nottingham Laboratory, the catheters will be subjected to qualitative and quantitative
analysis to determine the percentage of biofilm coverage on the surface. This will initially
be achieved using staining followed by microscopic visual examination of the catheter
surface, and images taken of any surface encrustation.
For Fluorescence Microscopy, the procedure will be:
1. Cut the catheter into segments then wash three times in ~15 ml of PBS with gentle
agitation.
2. Transfer the washed catheter segments into the wells of a sterile 24 well plate and
stain with SYTO17 Red Fluorescent Nucleic Acid Stain.
3. Segments will be imaged using a laser scanning confocal microscope using a 10 X
objective lens over a 1024 μm x 1024 μm area.
4. A z-section will be imaged (each section is 4μm apart with 36 images taken over 140μm)
such that the entire curved surface is imaged. The coverage data will then be taken from
a maximum intensity z-projection.
5. Data analysis will be carried out in ImageJ using the maximum intensity z-projection
images.
6. Images will be converted to 8-bit greyscale images, a threshold applied to select the
data correctly and the biofilm coverage measured.
7. The percentage of coverage for each sample will be computed as (Light) / (Light + Dark)
* 100%.
Aggregate descriptive statistics will be calculated, and biofilm coverage will be plotted
against the duration of catheterisation as a scattergram. The study is not powered to permit
statistical analysis.
Prior laboratory experiments predict that the difference in biofilm coverage could exceed
80%. If larger differences are seen in harvested catheters, then a Total Cell Count assay, in
which the biofilm is sonicated free of the surface and then assessed through serial dilution,
may be substituted for Fluorescence Microscopy.
