Computational protocol: Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)

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Protocol publication

[…] Progression of wound healing was evaluated by planimetric measurement of photographs, expressed as minimum diameter, maximum diameter, and area measured from day 1 to day 7. (Fig. ) Measurements were performed using ImageJ version 1.48 v (Wayne Rasband, National Institutes of Health, USA). (Supplementary Tables , , and ) Moreover, wound healing and condition were assessed in comparison to prior day (stable, improving, impaired) according to the following criteria: presence or absence of inflammation, presence or absence of exsudate on the dressing, presence or absence of re-epithelialization and presence or absence of undermining and tunneling. Local tolerability was evaluated using the following criteria: (0 = no visible reaction; 1 = faint, minimal erythema; 2 = erythema; 3 = erythema with induration or vesicles; and 4 = severe erythema with induration, vesicles, or bullae or pustules and/or erosion/ulceration).Figure 4 [...] Data obtained were evaluated statistically using R version 3.2.1., IBM SPSS Statistics version 23 (SPSS Inc., Chicago, USA), and GraphPad Prism 6 software (GraphPad Software Inc., La Jolla, CA, USA). The analyses were performed for the “as treated” population using descriptive statistics. For the continuous parameters of wound and scar assessment, means, standard deviations as well as medians, quartiles, minima and maxima were calculated separately for the two APOSEC groups and the placebo group as well as for the difference between APOSEC and placebo for all investigated days. […]

Pipeline specifications

Software tools ImageJ, SPSS
Applications Miscellaneous, Microscopic phenotype analysis
Organisms Homo sapiens
Diseases Wounds and Injuries