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

NCT05126017 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-11-18

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Birmingham

    collaborator OTHER

  • Welsh Burn Centre, Morriston Hospital, Swansea

    collaborator UNKNOWN

  • St. Andrews Burn Centre, Broomfield Hospital, Chelmsford

    collaborator UNKNOWN

  • The Scar Free Foundation

    collaborator UNKNOWN

  • University Hospital Birmingham NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-08-31
Completion
2023-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05126017 on ClinicalTrials.gov