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.