Examine the Validity of a Panel of Objective Burn Scar Measurement Tools

• Conditions: Burns; Scar; Hypertrophic

• Registration Number: NCT05126017
• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-17
• Last Update Submitted: 2021-11-17
• Study First Posted: 2021-11-18
• Last Update Posted: 2021-11-18
• Study Start: 2022-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global scar score from BOSS-1	24 months	Validate the accuracy of the global scar score that was created in Boss-1 in a larger population sequentially from time of healing to full scar maturation.

Secondary Outcome Measures

Name	Time	Method
Decorin	24 months	Immunohistochemistry staining for scar bio-biomarkers including: Decorin
Time to 100% healing	24 months	Complete wound healing from time of injury
Clinician and patient satisfaction with the various devices	24 months	Clinicians and patients will be given a questionnaire at the end of assessments to find out their satisfaction with the devices in terms of comfort, ease of use, and duration.
Early objective global scar score may predict long term outcome	24 months
Correlation of the scores of the objective scar assessment devices to subjective scar measurement scales	24 months
Vitamin D	24 months
TGF-levels from the serum	24 months	Immunohistochemistry staining for scar bio-biomarkers including: Transforming Growth Factor (TGF)