Examine the Validity of a Panel of Objective Burn Scar Measurement Tools (BOSS-2)

A Prospective Study to Examine the Validity of a Panel of Objective Burn Scar Measurement Tools

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns; Scar; Hypertrophic

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 Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global scar score from BOSS-1	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to 100% healing	Complete wound healing from time of injury	24 months
Clinician and patient satisfaction with the various devices	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.	24 months
Correlation of the scores of the objective scar assessment devices to subjective scar measurement scales		24 months
Early objective global scar score may predict long term outcome		24 months
Vitamin D		24 months
Decorin	Immunohistochemistry staining for scar bio-biomarkers including: Decorin	24 months
TGF-levels from the serum	Immunohistochemistry staining for scar bio-biomarkers including: Transforming Growth Factor (TGF)	24 months

Collaborators and Investigators

• Sponsor: University Hospital Birmingham NHS Foundation Trust
• Collaborators: University of Birmingham; Welsh Burn Centre, Morriston Hospital, Swansea; St. Andrews Burn Centre, Broomfield Hospital, Chelmsford; The Scar Free Foundation

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: burns; scars; scar assessment; objective assessment; objective scar scale; scar assessment reliability; scar assessment validation
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: RRK7292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No