Simulator study compares PLA/PCL patch with umbilical cord graft for fetal duraplasty

Fetoscopic prenatal repair of myelomeningocele may require a dural substitute. In this randomized crossover simulator study, 27 medical professionals—nine experts, nine intermediate-level participants and nine novices—performed four repair tasks using a novel PLA/PCL patch and a human umbilical cord (HUC) graft. Researchers recorded task times and collected task-difficulty ratings and NASA Task Load Index (NASA-TLX) scores.

Patch introduction was faster with PLA/PCL than with HUC (16 ± 7 vs 35 ± 17 seconds; p < 0.001), as was manipulation (50 ± 29 vs 69 ± 36 seconds; p = 0.05). Placement took longer with PLA/PCL (79 ± 71 vs 43 ± 23 seconds; p = 0.017). Suturing and total procedural times did not differ. NASA-TLX scores indicated lower physical demand (p = 0.003) and effort (p = 0.018) with the patch. Most participants rated the patch easier for each task, although this was a subjective assessment.

The findings suggest the patch’s pre-folded, shape-memory design may facilitate some steps in simulated fetoscopic repair. The study assessed performance in a simulator, not clinical outcomes; the authors state that further preclinical evaluation is needed before drawing conclusions about its use in patients.