BurnsBOSS-2NCT05126017
Examine the Validity of a Panel of Objective Burn Scar Measurement Tools
An observational study of Burns and Scar, run by University Hospital Birmingham NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Burns, Scar, Hypertrophic
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns, Scar, Hypertrophic
- Keywords
- burns, scars, scar assessment, objective assessment, objective scar scale, scar assessment reliability, scar assessment validation
- Medical subject headings
- Burns, Cicatrix, Hypertrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (7)
Time to 100% healing
Complete wound healing from time of injury
Measured: 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.
Measured: 24 months
Correlation of the scores of the objective scar assessment devices to subjective scar measurement scales
Measured: 24 months
Early objective global scar score may predict long term outcome
Measured: 24 months
Vitamin D
Measured: 24 months
Decorin
Immunohistochemistry staining for scar bio-biomarkers including: Decorin
Measured: 24 months
TGF-levels from the serum
Immunohistochemistry staining for scar bio-biomarkers including: Transforming Growth Factor (TGF)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study startJan 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, Welsh Burn Centre, Morriston Hospital, Swansea, St. Andrews Burn Centre, Broomfield Hospital, Chelmsford, The Scar Free Foundation
- Responsible party
- Principal investigator, Naiem Moiemen, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126017
- Sponsor's protocol ID
- RRK7292
- Acronym
- BOSS-2
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Examine the Validity of a Panel of Objective Burn Scar Measurement Tools
- ClinicalTrials.gov ID
- NCT05126017
- Acronym / sponsor ID
- BOSS-2 / RRK7292
- Conditions
- Burns, Scar, Hypertrophic
- Keywords
- burns, scars, scar assessment, objective assessment, objective scar scale, scar assessment reliability, scar assessment validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Birmingham, Welsh Burn Centre, Morriston Hospital, Swansea, St. Andrews Burn Centre, Broomfield Hospital, Chelmsford, The Scar Free Foundation
- Study start
- Jan 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global scar score from BOSS-1
Time frame: 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.
7 secondary outcomes
Time to 100% healing
Time frame: 24 months
Clinician and patient satisfaction with the various devices
Time frame: 24 months
Correlation of the scores of the objective scar assessment devices to subjective scar measurement scales
Time frame: 24 months
Early objective global scar score may predict long term outcome
Time frame: 24 months
Vitamin D
Time frame: 24 months
Decorin
Time frame: 24 months
TGF-levels from the serum
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Scar, run by University Hospital Birmingham NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global scar score from BOSS-1 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.