Wound Healing Probability Analysis

All statistical analyses were calculated using the Stata program (StataCorp, College Station, Texas). Kaplan-Meier survival analysis and a log-rank test were used to estimate healing probabilities for stratified baseline wound areas of 15 cm² or less, between 15 and 25 cm², and 25 cm² or larger. A Bonferroni correction was applied to the P value calculated through the log-rank test. A Cox proportional hazard model was used to assess the ability of baseline wound area size to predict healing outcomes. The proportional hazard assumption was met. A 95% confidence interval (CI) was calculated and included where appropriate. All statistical significance was analyzed with a two-sided α of .05. Continuous data are expressed as mean ± SD unless indicated otherwise. Safety and demographic analyses were presented using the intent-to-treat population. Efficacy analyses followed the published literature^{12 (link)} by presenting the per-protocol population first to provide a fair comparison.