Author | Year | Study type | Intervention and size of the group | Evaluation frequency | Follow-up time | Healing time(days) /(SD) | Healed percentage | Recurrences | Adverse outcomes. (amniotic membrane product related) | |
---|---|---|---|---|---|---|---|---|---|---|
1 | Thompson et al. [1] | 2019 | RCT | Human amniotic allograft 7 SOC-6 | Weekly | 12 weeks | I-29.50(15.41) C- 26.20(8.93) (p value has not been calculated due to small sample size) | NA | 90-day recurrence rate I-14.29% C-83.3% | NA |
2 | Tettebach et al. [5] | 2019 | RCT | dHACM – 54 SOC- 56 | Weekly | 12 weeks | P = 0.0187 (Kaplan–Meier plot of time to heal) | I-70% C-50% P = 0.0338 | 112-day recurrence I-5% C-14% | 3 product related events |
3 | Didomenico et al. [9] | 2016 | RCT | AmnioBand 20 SOC 20 | Weekly | 12 weeks | I – 36.0 C – 70.0 P = 0.00073 | I-85%, C-25% P = 0.00073 Odds ratio = 17 | NA | NA |
4 | Snyder et al. [10] | 2016 | RCT | AMNIOEXCEL 15 SOC 14 | Weekly | 6 weeks | NA | I-35%, C-0% P = 0.017 | NA | Not observed |
5 | Zelen et al.[11] | 2015 | RCT | EpiFIx 32 Apligraf 33 SOC 35 | Weekly | 12 weeks | I1-23.6 I2- 47.9 C = 57.4 | I1-97% I2-73% C-51 P = 0.0019 | NA | Not observed |
6 | Zelen et al. [12] | 2014 | RCT | Epifix 20 SOC 20 | I – weekly C—biweekly | 12 weeks | I-16.8(12.6) C-29.0(17) P = 0.039 | I-85% C-100% | NA | Not observed |
7 | Lavery et al. [13] | 2014 | RCT | Grafix 50 SCO 47 | Weekly | 12 weeks | I-42.0 C-69.5 P = 0.019 | I-62.0% C-21.3% P = 0.0001 | NA | Would infections were low in interventional group (p = 0.044) |
8 | Zelen et al. [2] | 2013 | RCT | Epifix 13 SOC 12 | Weekly | 6 weeks | I-17.5(13.3) C-35.0 | I-92% C-8% P = 0.0001 | NA | NA |
9 | Valiente et al. [14] | 2018 | Prospective Case series | Cryopreserved amniotic membrane 14 | Weekly | Until complete closure | Median time 20 weeks (range 7–56) | NA | NA | Not observed |
10 | Abdo [15] | 2016 | Prospective Cases series | AMNIOEXCEL 14 | Weekly | Until complete closure | Median 5 weeks (range 1014 weeks) | NA | NA | NA |
11 | Raphael [16] | 2016 | Retrospective study | NEOX CORD 1 K (cryopreserved amniotic membrane) 29 | Weekly | Until complete closure | Mean 96.6(13.65) days Median 9 weeks | 87.5% | NA | NA |
12 | Kirsner et al. [17] | 2015 | Retrospective study | dHACM 63 | NA | 24 weeks | Median time 26 weeks | At 12 weeks-28% At 24 weeks-47% | NA | NA |