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

NCT05126017 | Unknown

• 1 other identifier: RRK7292
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burns; Scar; Hypertrophic

Keywords

burns; scars; scar assessment; objective assessment; objective scar scale; scar assessment reliability; scar assessment validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to 100% healing

  24 months

• Clinician and patient satisfaction with the various devices

  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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloods and skin biopsy

MeSH Terms

Conditions

Burns; Cicatrix; Hypertrophy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Burns and Plastics Consultant

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 18, 2021
• Study Start: January 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share