Safety and Hemostatic Effectiveness of SURGICEL® Powder in Mild and Moderate Intraoperative Bleeding

Abstract

This postmarket clinical study evaluated the safety and effectiveness of the novel adjunctive topical hemostat SURGICEL® Powder (SURGICEL®-P), a powdered form of oxidized regenerated cellulose. In a prospective, open-label, single-arm multicenter trial, adult surgical subjects with mild-to-moderate bleeding for which conventional hemostatic methods were impractical/ineffective were treated with SURGICEL®-P. Descriptive analyses included hemostatic success rate at 3, 5, and 10 min, rebleeding and thromboembolic events, SURGICEL®-P-related serious adverse events requiring surgical intervention, and SURGICEL®-P ease of use (questionnaire). In 8 centers, 103 subjects were enrolled with a median (range) age of 64.0 (33.0-88.0) years. Surgeries were open (53.4%) or laparoscopic/thoracoscopic (46.6%) and mostly urological (37.9%) and abdominal (32.0%) procedures. Bleeding sites included various tissue types, with a median (range) surface area of 4 (0.02-72.0) cm2. Hemostatic success rates were 77.7%, 87.4%, and 92.2% at 3, 5, and 10 min, respectively. In 7 subjects (6.8%), investigators reverted to standard of care. No safety signals were identified. Two deaths occurred with causes unrelated to SURGICEL®-P. Investigators favorably evaluated the ease of use of the SURGICEL®-P device. SURGICEL®-P is safe and effective in controlling mild-to-moderate bleeding in a broad range of surgical procedures. The trial was registered at https://clinicaltrials.gov as NCT03762200.

Hypersensitive Reaction of Oxidized Regenerated Cellulose Powder in Total Knee Arthroplasty

“…Lin et al [ 17 ] also reported severe pelvic abscess formation after laparoscopic myomectomy caused by intraoperative ORC placement. Al-Attar et al [ 6 ] recommended irrigating or aspirating excess powder once hemostasis is achieved while simultaneously leaving the clot undisturbed.…”

“…Currently, many surgical fields utilize ORC powder as an absorbable hemostatic material [ 7 ]. The material acts as a stable matrix for clot formation; furthermore, the material also enhances platelet activation and adhesion [ 6 ]. Moreover, ORC has been reported to produce antibacterial effects in a wound-healing animal model due to its creation of local acidic conditions [ 20 ].…”

“…Powdered oxidized regenerated cellulose (ORC powder) is a widely used biodegradable hemostatic material [ 6 ]. In recent years, ORC powder has been used as an absorbable hemostatic agent in different clinical fields, including neurosurgery, thoracic surgery, general surgery, urologic surgery, and gynecologic surgery [ 7 ].…”

Rational Design of Bioactive Materials for Bone Hemostasis and Defect Repair

“…After the investigation of various natural and synthetic biomaterials, surgeons can obtain a wide range of hemostatic materials (e.g., hydrogel [ 16 ], robust bandage [ 17 ], bioadhesive [ 18 ], bio-glue [ 19 ], and hemostatic powder [ 20 ]) to treat externally palpable injuries. Although some reviews have provided valuable guidance for designing hemostatic materials and scaffold materials [ 21 – 24 ], comprehensive studies focusing on bone hemostasis and bone repair are still absent.…”