Study of FS2 Cream to Reduce Scarring After Skin Graft Surgery in Burn Patients Aged 12 to 65

What this Trial Is About

Researchers are evaluating how a cream containing kynurenic acid, called FS2, affects scar formation in people with burn injuries who need skin graft surgery. This study aims to understand whether FS2 is safe and helpful in reducing scarring at both the skin graft and donor sites after surgery. The trial is a double-blind, randomized study with some parts masked to both patients and investigators. Participants will use either a control cream without FS2 or a treatment cream containing 0.5% FS2 on the donor and graft sites for the first 90 days without knowing which they receive. After this period, all participants will apply the FS2 cream openly for an additional 90 days. The study includes detailed photography and scar assessments using tools like POSAS and VSS at multiple time points. During the study, participants will have their graft and donor sites regularly examined and scored for scar condition up to Day 180. Quality of life will also be assessed using the Burn Specific Health Scale-Brief BSHS-B. The study includes various visits for assessments, and safety and scar improvement are carefully monitored. Total participation may last around six months, with interim analyses planned to guide study direction.

Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients