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Page 6 of 14 Pignet et al. Plast Aesthet Res 2024;11:40 https://dx.doi.org/10.20517/2347-9264.2024.54

Table 1. Clinical studies evaluating the use of acellular fish skin in burn and complex trauma wounds
N Fish skin Treatment
Study Study type Comparison to Condition End points
(total) product period
Lima Júnior Randomized, 62 Nile Tilapia Silver Superficial and Until > 95% re- Re-epithelialization
[14]
et al., 2020 monocentric, open- FSG sulfadiazine deep partial- epithelialization)
label clinical study cream (1%) thickness burns
phase II
Lima Júnior Randomized, 115 Nile Tilapia Silver SPTB Until full re- Re-epithelialization
[18]
et al., 2020 monocentric, parallel, FSG sulfadiazine epithelialization
open-label, controlled cream (1%)
pilot clinical study
phase III
Lima Júnior Randomized, 30 Nile Tilapia Silver SPTB Until > 95% re- Re-epithelialization
[23]
et al., 2020 monocentric open- FSG sulfadiazine epithelialization
label, controlled clinical cream (1%)
study phase II
Costa et al., Case report 1 Nile Tilapia / SPTB in a child Until full re- Re-epithelialization
2019 [17] FSG epithelialization
Wallner et al., Controlled 12 Kerecis® STSG Deep partial- Not stated Not stated
[16]
2022 retrospective cohort Omega3 thickness burns
study Wound
Matrix
Yoon et al., Controlled cohort study 52 Kerecis® No treatment + Donor site Until full re- Re-epithelialization
[6]
2022 Omega3 bovine collagen epithelialization
Wound matrix
Matrix
Badois et al, Controlled cohort study 21 Kerecis® Paraffin gauze Donor site Until full re- Re-epithelialization
[24]
2019 Omega3 epithelialization
Wound
Matrix
Alam et al., Case series 10 Kerecis® / Donor site Until full re- Re-epithelialization
[15]
2019 Omega3 epithelialization
Wound
Matrix
Reda et al., Case series 3 Kerecis® / Combat injuries Not consistently Not stated
2023 [20] Omega3 stated
Wound
Matrix
Smolle et al., Case report 1 Kerecis® / Epifascially Until suitable Infection control and
2023 [25] Omega3 debrided burn wound conditions sufficient granulation
Wound wound for STSG for STSG
Matrix
Kirsner et al., Prospective, double- 170 Kerecis® dHACM allograft Acute full- Until full re- Re-epithelialization
[11]
2020 blinded RCT Omega3 thickness epithelialization
Wound wound
Matrix
STSG: Split-thickness skin graft; dHACM: dehydrated human amnion/chorion membrane.

In contrast, in a phase III study, which was conducted in patients with SPTB of < 15% TBSA, Lima Júnior
et al. re-applied the sulfadiazine cream in the control group every 48 h . Still, a significantly lower (P <
[18]
0.001) number of dressing changes (1.6 ± 0.7) was observed in the NTG group, with a mean difference of 3.3
[23]
[18]
days . Similar results were achieved in another study conducted in a pediatric population (P < 0.001) .
A reduction in the number of dressing changes represents not only a decrease in the individual cost of
treatment but also a reduction in the overall workload for healthcare staff.

Reduction in pain intensity
In the above-mentioned study by Lima Júnior et al., pain was assessed before and after dressing changes
using the visual analog scale (VAS) and the Electronic von Frey to measure changes in mechanical pain