Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05126017 |
| Other study ID # |
RRK7292 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2022 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
November 2021 |
| Source |
University Hospital Birmingham NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Reliable scar assessment is essential not only when designing clinical trials to investigate
the efficacy of new and existing scar therapies, but also in everyday, clinical practice, to
examine the progress of our patients' care. Subjective assessments are extremely important;
they demonstrate to the patient the changes and improvements in their scars since the primary
burn injury. Nevertheless, clinicians require reliable, validated, and objective tools which
can yield measurable and reproducible outcomes. These are ultimately needed to achieve the
goal of reducing the physical and psychosocial burden of scarring through compelling
research.
Previously, a pilot study (BOSS-1) was conducted in 55 patients with post burn hypertrophic
scars. The investigators measured, among other parameters, scar thickness, density, and
pliability, using a panel of objective scar assessment tools, alongside standard subjective
measurements (questionnaire-based), and skin biopsy assessments. Measurements were performed
at a single time point which varied from 3 months to 6 years post burn injury. This work
indicated that measuring scar thickness, pliability and colour together, may provide a global
scar objective score.
BOSS-2 is a multi-centre study that will validate the preliminary findings in BOSS-1.
Description:
The study will recruit 60 burn patients with a burn wound > 1% TBSA that did not achieve 100%
wound healing at 3 weeks post injury. Healed wounds will be assessed at 4 time points (3, 12,
18 and 24 months) from time of injury until scar maturation. From the time of recruitment (3
weeks post injury) the open wounds will be closely monitored (clinical assessments,
photography and trans-epidermal water loss (TEWL)) until time of complete wound closure will
be recorded. The time to healing will be used as a "recognised standard" to validate both the
objective and the subjective tools; time to healing has previously been shown to correlate
with severity of hypertrophic scarring.
A panel of tools, rather than a single device, has been selected since they capture all scar
characteristic changes (thickness, pliability and colour) during the scar maturation process.
These objective measurements along with subjective (e.g. POSAS, Vancouver) assessments will
be recorded at each time point. At the same time points, blood samples will be taken and 5mm
punch biopsy will be taken from SIFTI-2 cohort co-enrolled with BOSS-2 at Queen Elizabeth
Hospital Birmingham (QEHB).
The proposed project will: (1) validate the global burn objective scar score, identified in
BOSS-1 study; (2) correlate objective versus subjective measures; (3) assess the
acceptability of the global scar score with clinicians and patients; (4) correlate the
clinical outcomes with tissue and blood scarring markers.
The creation of a validated panel of objective scar measurement devices will form the basis
of future scar therapy research (outcome measures for clinical trials). These tools coupled
with the haematological and histological data will further the understanding of the process
of burn scar maturation and guide future care management.
