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Postoperative adhesions are a frequent and serious complication of abdominal and pelvic surgeries, leading to chronic pain, infertility, and intestinal obstruction, with significant clinical, and economic burdens. While barrier agents are widely used for prevention, current solutions often suffer from limited efficacy and short retention times. This study evaluates the dual-functionality of a polysaccharide-based medical device, 4SEAL Hemostatic Powder, by evaluating hemostatic performance and the reduction of postoperative adhesions. Using rat models, the hemostatic efficacy of 4SEAL was assessed via a standardized liver incision protocol, while its anti-adhesive properties were compared to hyaluronic acid and saline controls following ovariohysterectomy. Outcomes measured included time to hemostasis, number and severity of adhesions, and comprehensive histological, hematological, biochemical, and metabolic analyses to assess safety and tissue response. In addition, the absorption profile of 4SEAL, in both gel and powder forms, was evaluated using a murine model. 4SEAL Hemostatic Powder significantly shortened time to hemostasis (2.14±0.39 min vs. 4.30±2.02 min for untreated controls, p = 0.003) and decreased both the number of adhesions (powder: 0.85±0.75, gel: 1.0±0.92 vs. 2.9±1.29 for controls, p<0.01) and adhesion severity (powder: 3.75±2.67, gel: 3.55±3.19 vs. 7.7±4.88 for controls, p<0.05). Hyaluronic acid reduced adhesion number (1.6±2.27, p<0.05) but not severity (4.8±4.44, not statistically significant). Histological analysis indicated more advanced tissue regeneration and lower levels of fibrosis in 4SEAL-treated animals. No significant systemic biochemical or metabolic alterations were observed in the 4SEAL groups, supporting its biocompatibility. The findings indicate that 4SEAL Hemostatic Powder is effective in promoting hemostasis and reducing postoperative adhesion formation in preclinical models. The material demonstrated biocompatibility and biodegradability, supporting its potential utility as a dual-function surgical adjunct.
Published in: Macromolecular Bioscience
Volume 26, Issue 3, pp. e00664-e00664