IDEAL Phase 1 evaluation of subungual tube placement with selective nail-fold wedge resection for moderate-to-severe onychocryptosis-associated paronychia.

BACKGROUND: Onychocryptosis-associated paronychia is a common condition with frequent recurrence after conventional treatment. Minimally invasive, nail-preserving strategies remain insufficiently standardized and have not been extensively evaluated within structured clinical-development frameworks. This study reports the findings of an IDEAL Phase 1 (Idea) study investigating the technical feasibility, early safety, and preliminary clinical outcomes of subungual tube placement combined with selective nail-fold wedge resection for the treatment of moderate-to-severe onychocryptosis-associated paronychia. METHODS: This prospective, single-arm, single-center case series enrolled 11 consecutive patients with moderate-to-severe onychocryptosis-associated paronychia. According to predefined criteria based on the severity of nail-fold hypertrophy and fibrosis, three patients underwent subungual tube placement combined with selective nail-fold wedge resection, whereas eight underwent isolated subungual tube placement. Outcomes included healing time, pain intensity measured using the Visual Analog Scale (VAS), and recurrence rate. RESULTS: All procedures were completed successfully. The mean healing time was 5.8 weeks in the isolated tube placement group and 6.5 weeks in the combined treatment group. In the overall cohort, the median preoperative VAS score was 6. In the subgroup analysis, the median preoperative VAS score was 5 in the subungual tube placement alone group and 6 in the combined treatment group. At 1 week after surgery, the median VAS score decreased to 1 in the subungual tube placement alone group and to 2 in the combined treatment group. The only observed postoperative complication was transient localized bleeding, which resolved spontaneously within 72 h. No recurrence was observed in any of the 19 treated nail margins during follow-up through 12 months. Patients reported satisfaction with both cosmetic and functional outcomes. Three key procedural refinements were introduced during technique development to improve procedural feasibility and standardization. CONCLUSION: This IDEAL Phase 1 study demonstrates the technical feasibility and short-term safety of subungual tube placement combined with selective nail-fold wedge resection for moderate-to-severe onychocryptosis-associated paronychia. Early outcomes were characterized by favorable healing and rapid pain relief, with no recurrence observed during the available follow-up period. Further investigation is required to determine the optimal catheter design and refine patient-selection criteria. Future research should proceed to an IDEAL Phase 2 (Exploration) study incorporating a larger cohort, longer follow-up, and continued refinement and standardization of the technique.