This multicenter RCT (53 hospitals in Japan, Sept 2020–June 2023) evaluated SI-449 — a cross-linked, powder-form chondroitin sulfate adhesion barrier (2–3 g applied to the abdominal/pelvic cavity before closure) — vs. no barrier in adults undergoing open rectal resection for clinical stage I–IV rectal cancer, with adhesion assessment at planned ileostomy closure.
Adhesion incidence was significantly lower with SI-449 (45%, 26/58) vs. control (93%, 56/60) (P < .001); adhesion severity and extent were also significantly reduced. No safety concerns were identified.
Open-label design (PROBE method) limits blinding for operators; single-country (Japan) cohort may limit generalizability; relatively small modified ITT population (n=118) and short follow-up tied to ileostomy closure timeframe.
In open rectal resection requiring a temporary ileostomy, applying SI-449 chondroitin sulfate powder before abdominal closure nearly halved adhesion rates compared to no barrier (45% vs. 93%). Surgeons performing planned re-entry procedures may consider this agent as a practical, powder-based anti-adhesion option.
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