Clinical trial NCT05126017: Examine the Validity of a Panel of Objective Burn Scar Measurement Tools
Official title: A Prospective Study to Examine the Validity of a Panel of Objective Burn Scar Measurement Tools
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burns
Scar
Hypertrophic
Keywords: burns
scars
scar assessment
objective assessment
objective scar scale
scar assessment reliability
scar assessment validation
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Birmingham
name: Welsh Burn Centre, Morriston Hospital, Swansea
name: St. Andrews Burn Centre, Broomfield Hospital, Chelmsford
name: The Scar Free Foundation
First posted: 2021-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All burn patients with burn TBSA \>1% deep dermal/full thickness with unhealed burns wounds (\<100% healing) at 3 weeks from time of injury.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Any individual with burns injury aged ≥ 16 years old.
* Any deep dermal/ full thickness burn but the size must be minimum \>1% TBSA
* Patients who can provide informed consent.
* Those treated with split thickness skin grafts or conservatively managed burn wounds which had taken \> 3 weeks to heal (\<100% healing).

Exclusion Criteria:

* Burns to genitalia, face
* Patients with skin conditions/diseases (pathological fibrosis e.g. scleroderma; pathological thinning e.g. epidermolysis bullosa; collagen disorders e.g. Marfan's syndrome)
* Contraindications to method of scar assessment e.g. known allergy to ultrasound gel
* Chronic steroid use; history of skin malignancy or chronic papulo-squamous disease (e.g. eczema, pemphigus); history of Steven Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) disease
* Patients with history of keloid formation

Primary outcomes:
measure: Global scar score from BOSS-1
timeFrame: 24 months
Secondary outcomes:
measure: Time to 100% healing
timeFrame: 24 months
measure: Clinician and patient satisfaction with the various devices
timeFrame: 24 months
measure: Correlation of the scores of the objective scar assessment devices to subjective scar measurement scales
timeFrame: 24 months
measure: Early objective global scar score may predict long term outcome
timeFrame: 24 months
measure: Vitamin D
timeFrame: 24 months
measure: Decorin
timeFrame: 24 months
measure: TGF-levels from the serum
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
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