A Pilot Randomised Controlled Trial Evaluating a Regenerative Epithelial Suspension for Medium-Size Partial-Thickness Burns in Children: The BRACS Trial
Abstract
:1. Introduction
2. Materials and Methods
Statistical Methods
3. Results
3.1. Participant Recruitment
3.2. Demographic Data
3.3. Primary Outcome: Time to Re-Epithelialisation
3.4. Secondary Outcomes
3.4.1. Pain
3.4.2. Itch Intensity
3.4.3. Ease of Dressing Application
3.4.4. Intervention Fidelity
3.4.5. Treatment Satisfaction
3.4.6. Scar Severity
Outcome | Silver Dressings | RES™/Biobrane® | Biobrane® | |||
---|---|---|---|---|---|---|
Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | |
Scar Characteristics | ||||||
Thickness (n, mm) | 5 | 4 | 4 | |||
1.32 (0.85–2.92) | 1.77 (1.22) | 1.08 (0.97–1.49) | 1.18 (0.29) | 1.59 (1.35–2.94) | 1.96 (0.94) | |
Colour (n) | 4 | 4 | 5 | |||
L*Scar | 32.10 (15.61–40.90) | 29.54 (14.06) | 35.78 (15.80–41.26) | 30.95 (14.46) | 39.13 (30.05–45.00) | 38.06 (8.18) |
L*Normal | 29.84 (26.60–40.89) | 32.44 (8.12) | 32.18 (16.53–46.78) | 31.53 (16.10) | 43.73 (33.80–46.58) | 41.37 (7.26) |
a*Scar | 14.23 (9.91–18.70) | 14.28 (4.62) | 13.35 (10.05–16.84) | 13.41 (3.55) | 15.12 (13.07–17.57) | 15.25 (2.34) |
a*Normal | 13.53 (12.57–14.38) | 13.49 (0.98) | 13.24 (11.17–15.76) | 13.24 (2.57) | 11.23 (10.16–15.88) | 12.43 (3.40) |
b*Scar | 13.94 (10.88–16.85) | 13.89 (3.09) | 14.29 (8.88–16.87) | 13.35 (4.30) | 9.35 (3.28–18.11) | 10.24 (7.84) |
b*Normal | 16.87 (15.02–18.27) | 16.72 (1.73) | 15.61 (10.91–18.26) | 14.93 (3.95) | 14.85 (12.77–18.94) | 15.52 (3.33) |
Clinician Scar Severity Report OSAS(n) ‡ | 5 | 4 | 4 | |||
Overall Opinion | 2.00 (2.00–5.50) | 3.40 (3.13) | 2.00 (1.25–2.75) | 2.00 (0.82) | 2.50 (2.00–6.75) | 3.75 (2.87) |
Treatment Satisfaction | ||||||
Doctor (n ¥) | 7 | 9 | 7 | |||
8.00 (7.00–9.00) | 7.57 (2.23) | 9.00 (8.50–9.50) | 9.00 (0.71) | 5.00 (4.00–15.00) | 5.57 (1.90) | |
Nurse (n ¥) | 0 | 1 | 0 | |||
N/A | 9.00(9.00–9.00) | N/A | ||||
Occupational Therapist (n ¥) | 1 | 1 | 3 | |||
8.00 (8.00–8.00) | 8.00 (_) | 7.00 (7.00–7.00) | 7.00 (_) | 8.00 (8.00–_) | 8.33 (0.58) |
3.4.7. Health-Related Quality of Life
Outcome | Silver Dressings | RES™/Biobrane® | Biobrane® | |||
---|---|---|---|---|---|---|
Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | |
POSAS † (n) | 7 | 5 | 4 | |||
Overall Opinion | 3.00 (1.00–6.00) | 3.86 (2.97) | 2.00 (1.00–3.50) | 2.20 (1.64) | 3.50 (3.00–5.50) | 4.00(1.41) |
POSAS Score | 14.00 (6.00–27.00) | 18.00 (14.06) | 9.00 (4.00–13.00) | 8.60 (5.18) | 22.50 (14.75–30.25) | 22.50(8.27) |
BBSIP † (n) | 7 | 5 | 4 | |||
Overall impact of burns | 1.13 (1.00–3.00) | 1.71 (0.95) | 1.00 (1.00–1.00) | 1.00 (0.00) | 1.38 (1.09–1.56) | 1.34 (0.26) |
Treatment Satisfaction ≠ (n) | 10 | 8 | 6 | |||
Parent/Guardian | 10.00 (8.25–10.00) | 9.10 (1.66) | 10.00 (10.00–10.00) | 10.00 (0.00) | 9.50 (9.00–10.00) | 9.50 (0.55) |
3.4.8. Health Resource Utilisation
3.4.9. Adverse Events
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Registration
Protocol
Abbreviations
ACHD | Autologous Cell Harvesting Device |
ASCS | Autologous Skin Cell Suspension |
AUD | Australian Dollar |
BBSIP | Brisbane Burn Scar Impact Profile |
BRACS | Biobrane®, RECELL® Autologous Skin Cell Suspension and Silver Dressings |
CHU9D | Child Health Utility 9D |
COD | Change of Dressing |
FLACC | Face, Legs, Activity, Cry, Consolability |
FPS-R | Faces Pain Scale-Revised |
HREC | Human Research Ethics Committee |
IQR | Interquartile Range |
MAX | Maximum |
MIN | Minimum |
NRS-I | Numeric Rating Scale—Itch |
NRS-I Proxy | Numeric Rating Scale—Itch Proxy |
NRS-P | Numeric Rating Scale—Pain |
NRS-P Proxy | Numeric Rating Scale—Pain Proxy |
OSAS | Observer Scar Assessment Scale |
POSAS | Patient and Observer Scar Assessment Scale |
QUT | Queensland University of Technology |
REDCap | Research Electronic Data Capture |
RES™ | Regenerative Epidermal Suspension |
SSA | Site Specific Approval |
TBSA-B | Burn Total Body Surface Area |
TTRE | Time to re-epithelialisation |
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Parameter (n) | Silver Dressings ‡ (8) | RES™/Biobrane® (7) | Biobrane® (7) |
---|---|---|---|
Age (years) * | 1.50 (1.00–2.75) | 1.00 (1.00–2.00) | 2.00 (2.00–4.00) |
Age (years, Min–Max) | 0.00–14.00 | 1.00–14.00 | 1.00–9.00 |
Gender (n) | M4: F4 | M5: F2 | M1: F6 |
Ethnicity (n) | |||
European | 3 | 2 | 3 |
Aboriginal or Torres Strait Islander | 1 | 1 | 2 |
Asian | 2 | 2 | 1 |
Middle Eastern | - | - | - |
African | - | 1 | - |
Other | 2 | 1 | 1 |
Fitzpatrick Skin Type (n) | |||
I | 1 | - | - |
II | - | 1 | - |
III | 2 | 2 | - |
IV | 1 | 4 | 3 |
V | 4 | - | 4 |
VI | - | - | - |
Co-morbidities (n) | |||
Allergies | 1 | - | - |
Skin disorders | 2 | - | 1 |
Physical disability | - | - | - |
Learning disability | 1 | 1 | 1 |
Mental health illness | - | 1 | 1 |
PTSS | 1 | - | - |
Visual Impairment | - | - | - |
Other | 2 | 1 | 3 |
Language (n) | |||
English | 4 | 3 | 6 |
Multi-lingual, including English | 4 | 4 | 1 |
Parameter (n) | Silver Dressings ‡ (8) | RES™/Biobrane® (7) | Biobrane® (7) |
---|---|---|---|
TBSA-B (%) | |||
Median (IQR) | 11.5 (7.0–15.75) | 6.00 (5.0–20.0) | 10.0 (8.0–15.0) |
Min–Max | 5–20 | 5–33 | 7–27 |
Burn Depth (n) | |||
Superficial thickness | 2 | 1 | 1 |
Superficial partial thickness | 8 | 7 | 7 |
Mid-Dermal partial thickness | 4 | 6 | 4 |
Deep partial thickness | 1 | 1 | 2 |
Injury mechanism (n) | |||
Scald | 7 | 6 | 5 |
Flame | - | 1 | 2 |
Radiant Heat | 1 | - | - |
Anatomical Location (n) | |||
Head/Neck | 8 | 6 | 6 |
Trunk | 8 | 7 | 7 |
Upper limb | 5 | 5 | 7 |
Hand | 3 | 2 | 2 |
Lower limb | 1 | 3 | 4 |
Foot | 8 | 2 | 7 |
Appropriate First Aid (n) | 8 | 6 | 7 |
Burn age at initial presentation (hours) * | 8.50 (2.25–21.00) | 9.00 (4.00–12.00) | 4.00 (3.00–6.00) |
Burn age at initial dressing application (hours) * | 13.00 (6.25–24.75) | 14.00 (10.00–20.00) | 6.00 (4.00–18.00) |
Outcome (n) | Silver Dressings ‡ (8) | RES™/Biobrane® (7) | Biobrane® (7) |
---|---|---|---|
Time to Re-epithelialisation (days) | |||
Mean TTRE (SD) | 15.1 (±8.87) | 11.1 (±3.28) | 15.1 (±6.04) |
Median TTRE (95%CI) | 12 (3.7–20.3) | 12 (5.6–18.4) | 14 (6.3–21.7) |
Number of dressing applications (n) | |||
Under general anaesthesia * | 3 (1.00–4.75) | 2 (1.00–3.00) | 3 (2.00–4.00) |
Awake * | 2 (2.00–4.00) | 4 (3.00–4.00) | 2 (2.00–4.00) |
Total * | 6 (3.00–7.75) | 6 (5.00–6.00) | 7 (5.00–8.00) |
Pain * | |||
Initial dressing application | |||
Median pre-intervention FLACC score | 2.00 (0.00–2.75) | 0.00 (0.00–3.25) | 0.00 (0.00–0.00) |
Median post-intervention FLACC score | 0.00 (0.00–0.00) | 0.00 (0.00–4.00) | 0.00 (0.00–2.50) |
Median difference FLACC score | −2.00 | 0.00 | 0.00 |
Median pre-intervention NRS-P Proxy score | 5.50 (3.00–9.50) | 7.00 (5.00–10.00) | 4.00 (3.00–4.75) |
Median post intervention NRS-P Proxy score | 2.00 (1.00–4.00) | 4.00 (0.00–8.50) | 2.50 (0.00–10.00) |
Median difference NRS-P Proxy score | −3.50 | −3.00 | −1.5 |
Dressing Change #1 | |||
Median pre-intervention FLACC score | 0.00 (0.00–1.75) | 0.00 (0.00–2.00) | 0.00 (0.00–0.00) |
Median post-intervention FLACC score | 0.00 (0.00–3.50) | 0.00 (0.00–0.00) | 0.00 (0.00–0.00) |
Median difference FLACC score | 0.00 | 0.00 | 0.00 |
Median pre-intervention NRS-P Proxy score | 1.00 (0.00–6.00) | 2.50 (0.00–5.50) | 1.00 (0.50–4.00) |
Median post intervention NRS-P Proxy score | 4.00 (0.00–5.00) | 2.00 (1.75–3.50) | 1.00 (0.00–2.00) |
Median difference NRS-P Proxy score | +3.00 | −0.50 | 0.00 |
Itch * | |||
Median NRS-I Proxy score | 6.00 (3.00–8.00) | 4.00 (2.25–7.00) | 4.00 (2.00–7.00) |
Ease of Dressing Application * | |||
Initial dressing application | |||
Doctors (n = 48) | |||
Application ease | 5.00 (2.00–6.00) | 6.50 (2.75–7.00) | 5.00 (3.00–7.00) |
Dressing conformability | 3.00 (2.00–7.00) | 3.50 (2.00–7.50) | 4.50 (2.7–6.00) |
Duration(minutes) | <60 | >60 | >60 |
Nurses (n = 26) | |||
Application ease | 2.00 (1.00–4.00) | 2.50 (1.00–8.75) | 1.00 (0.00–2.00) |
Dressing conformability | 3.00 (1.00–3.50) | 2.00 (1.00–5.00) | 1.00 (0.50–1.50) |
Duration(minutes) | <60 | <60 | <10 |
Dressing Change | |||
Doctors (n = 43) | |||
Application ease | 7.00 (4.25–7.75) | 4.00 (2.00–8.00) | 3.00 (2.00–7.00) |
Dressing conformability | 7.00 (5.00–7.00) | 2.00 (2.00–7.00) | 2.00 (2.00–7.00) |
Duration(minutes) | <60 | <60 | 30>, <60 |
Nurses (n = 101) | |||
Application ease | 2.00 (1.00–3.00) | 2.00 (1.00–4.00) | 1.50 (0.00–3.00) |
Dressing conformability | 2.00 (1.00–3.25) | 2.00 (0.25–4.25) | 2.00 (1.00–3.00) |
Duration (minutes) | <60 | <60 | 30>, <60 |
Intervention Fidelity * | |||
Initial dressing application (%) | |||
QV wash | 100 | 100 | 100 |
Intervention | 87.50 | 83.61 | 97.62 |
Dressing Change (%) | |||
QV wash | 89.47 | 72.22 | 76.19 |
Intervention | 94.08 | 90.79 | 100.00 |
Treatment Satisfaction * | |||
Staff | 9.00 (8.75–10.00) | 9.00 (8.00–9.75) | 8.00 (2.25–9.00) |
Parent/Guardian | 10.00 (9.00–10.00) | 10.00 (10.00–10.00) | 10.00 (9.00–10.00) |
Type of Adverse Event | Silver Dressings ‡ | RES™/Biobrane® | Biobrane® |
(n) | (13) | (8) | (10) |
Nil | 3 | 2 | 1 |
Wound infection | 2 | 1 | 3 |
Allergic reaction | 1 | 0 | 0 |
Sepsis | 1 | 0 | 0 |
Unplanned ICU admission | 2 | 1 | 2 |
Burn depth progression | 2 | 1 | 3 |
Required split-thickness skin graft | 2 | 0 | 1 |
Other | |||
Fever associated with teething | 0 | 1 | 0 |
Unplanned ward admission | 0 | 1 | 0 |
12-h delay to theatre | 1 | 0 | 0 |
Clavein–Dindo Grade of Complication | Silver Dressings ‡ | RES™/Biobrane® | Biobrane® |
(n) | (10) | (6) | (9) |
Grade I | 2 | 5 | 1 |
Grade II | 0 | 0 | 2 |
Grade IIIa | 0 | 0 | 0 |
Grade IIIb | 4 | 0 | 3 |
Grade IVa | 0 | 0 | 0 |
Grade IVb | 4 | 1 | 3 |
Grade V | 0 | 0 | 0 |
Clavein–Dindo Grade of Most Severe Complication | Silver Dressings ‡ | RES™/Biobrane® | Biobrane® |
(n) | (5) | (5) | (6) |
Grade I | 1 | 4 | 1 |
Grade II | 0 | 0 | 2 |
Grade IIIa | 0 | 0 | 0 |
Grade IIIb | 2 | 0 | 1 |
Grade IVa | 0 | 0 | 0 |
Grade IVb | 2 | 1 | 2 |
Grade V | 0 | 0 | 0 |
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Bairagi, A.; Tyack, Z.; Kimble, R.; Vagenas, D.; McPhail, S.M.; Griffin, B. A Pilot Randomised Controlled Trial Evaluating a Regenerative Epithelial Suspension for Medium-Size Partial-Thickness Burns in Children: The BRACS Trial. Eur. Burn J. 2023, 4, 121-141. https://doi.org/10.3390/ebj4010012
Bairagi A, Tyack Z, Kimble R, Vagenas D, McPhail SM, Griffin B. A Pilot Randomised Controlled Trial Evaluating a Regenerative Epithelial Suspension for Medium-Size Partial-Thickness Burns in Children: The BRACS Trial. European Burn Journal. 2023; 4(1):121-141. https://doi.org/10.3390/ebj4010012
Chicago/Turabian StyleBairagi, Anjana, Zephanie Tyack, Roy Kimble, Dimitrios Vagenas, Steven M. McPhail, and Bronwyn Griffin. 2023. "A Pilot Randomised Controlled Trial Evaluating a Regenerative Epithelial Suspension for Medium-Size Partial-Thickness Burns in Children: The BRACS Trial" European Burn Journal 4, no. 1: 121-141. https://doi.org/10.3390/ebj4010012