Evaluation of Surgi-ORC for Hemostasis and Safety in Gynecological Surgeries: A Multicenter Prospective Observational Pilot Study.

Background and Aims: Achieving adequate intraoperative hemostasis is critical in gynecological surgeries to reduce perioperative morbidity. Surgi-oxidized regenerated cellulose (ORC) is a biodegradable hemostatic agent that controls mild to moderate bleeding. This study aimed to generate preliminary observational data on the efficacy and safety of Surgi-ORC across a range of gynecological procedures. Methods: This prospective, multicentre, single-arm observational study was conducted at two centres in India. A total of 28 women undergoing gynecological surgeries, including hysterectomy, myomectomy, sacrohysteropexy, cystectomy with oophorectomy, laparotomy, and recanalization, received Surgi-ORC intraoperatively for bleeding control. Time to hemostasis (TTH), the association between product variants and TTH, the association of TTH across surgery types, short-term safety outcomes, and surgeon-reported usability were assessed. Follow-ups were conducted on postoperative Days 2, 28, and 60. Subgroup analyses were considered exploratory due to the limited sample size. Results: Hemostasis was achieved in all cases, with a mean TTH of 1.3 min (SD = 0.43). Descriptive evaluation showed broadly similar TTH values across surgery types and product variants; however, small and imbalanced subgroup sizes limited definitive conclusions. On Day 2, X-ray imaging showed no radiographic abnormalities attributable to retained material and was confirmed based on clinical judgment of the radiologist and operating surgeon. No device-related adverse events, complications, or short-term safety concerns were identified during the study period. Most surgeons rated handling characteristics as "Good" across all evaluated parameters, indicating favorable usability. Conclusion: This observational pilot study suggests that Surgi-ORC is effective in achieving hemostasis and demonstrates no short-term safety concerns during the 60-day follow-up along with satisfactory usability characteristics in gynecological procedures. However, given the exploratory nature of analysis, single-arm design, and small sample size, these findings should be interpreted cautiously, and larger comparative studies are required to further validate its clinical utility.