The study subjects are patients in our hospital's orthopedics department undergoing unilateral primary total knee arthroplasty (TKA) due to primary osteoarthritis. Through a prospective, parallel randomized controlled study, 112 participants will be divided into two groups: the SURGICEL® Powder group and the non-use group. The study will compare the total perioperative blood loss , intraoperative blood loss, transfusion rate and volume, postoperative hemoglobin decline, hematocrit decline, limb swelling rate , postoperative limb pain , and range of motion. Statistical analysis will be performed on the data to observe the hemostatic effects of SURGICEL® Powder, providing recommendations for the clinical use of SURGICEL® Powder.

Start Date30 Aug 2024

Sponsor / Collaborator

Peking University Third Hospital

100 Clinical Results associated with Cellulose Oxidized

100 Translational Medicine associated with Cellulose Oxidized

100 Patents (Medical) associated with Cellulose Oxidized

Literatures (Medical) associated with Cellulose Oxidized

01 Dec 2024·Endoscopy

Oxidized regenerated cellulose combined with hyperbaric oxygen therapy successfully managed delayed bleeding after peroral endoscopic myotomy for achalasia

Article

Author: Lin, Qiuling ; Wang, Lisheng ; Zou, Zhiyuan ; Zhang, Dingguo ; Zhan, Shenggang

01 Dec 2024·European Journal of Pediatric Surgery

A Study of Safety and Effectiveness of Evicel Fibrin Sealant as an Adjunctive Hemostat in Pediatric Surgery

Article

Author: Illie, Bogdan ; Barnett, Ellie ; Hall, Nigel J. ; Gabra, Hany ; Kocharian, Richard ; Sharif, Khalid ; Flageole, Helene ; Kenny, Simon

Introduction Data on the use of fibrin sealants to control intraoperative bleeding in children are scarce. Evicel Fibrin Sealant (Ethicon Inc., Raritan, New Jersey, United States) was found safe and effective in clinical trials of adults undergoing various surgery types. We evaluated the safety and efficacy of Evicel versus Surgicel Absorbable Hemostat (Ethicon Inc.) as adjunctive topical hemostats for mild/moderate raw-surface bleeding in pediatric surgery. Methods A phase III randomized clinical trial was designed as required by the European Medicines Agency's Evicel Pediatric Investigation Plan: 40 pediatric subjects undergoing abdominal, retroperitoneal, pelvic, or thoracic surgery were randomized to Evicel or Surgicel, to treat intraoperative mild-to-moderate bleeding. Descriptive analyses included time-to-hemostasis and rates of treatment success (4, 7, 10 minutes), intraoperative treatment failure, rebleeding, and thromboembolic events. Results Forty of 130 screened subjects aged 0.9 to 17 years were randomized 1:1 to Evicel or Surgicel. Surgeries were predominantly open abdominal procedures. The median bleeding area was 4.0 cm2 for Evicel and 1.0 cm2 for Surgicel. The median time-to-hemostasis was 4.0 minutes for both groups. The 4-, 7-, and 10-minute treatment success rates were 80.0% versus 65.0%, 100.0% versus 80.0%, and 95.0% versus 90.0%, whereas treatment failure rates were 5.0% versus 25.0%, for Evicel and Surgicel, respectively. No deaths or thrombotic events occurred. Re-bleeding occurred in 5.0% of Evicel and 10.0% of Surgicel subjects. Conclusions In accordance with adult clinical trials, this randomized study supports the safety and efficacy of Evicel for controlling mild-to-moderate surgical bleeding in a broad range of pediatric surgical procedures.

09 Nov 2024·Brain Injury

Massive traumatic epidural hematoma in a child with suprasellar arachnoid cyst and hydrocephalus

Article

Author: Cao, Hongbin ; Guo, Genrui

We present a case of a child with a suprasellar arachnoid cyst and hydrocephalus who developed a massive traumatic epidural hematoma following a fall. This represents the first reported case of such a condition. The case is characterized by a progressive increase in hemorrhage leading to a massive hematoma, yet with relatively mild clinical symptoms. The hemorrhage originated from extensive blood seepage from the dura mater. Intraoperative hemostasis was challenging, and there was a large residual cavity of the epidural hematoma without repositioning of brain tissue after removal of the hematoma. Surgical measures such as extensive continuous compression hemostasis with Surgicel, the half-suspension technique, and continuous external drainage were employed to address these challenges. A second-stage surgery for the treatment of the suprasellar arachnoid cyst was performed 1.5 months after hematoma evacuation, utilizing neuroendoscopic ventriculocisternostomy (VCC). We recommend that for patients with traumatic brain injury and hydrocephalus, especially those with skull fractures or minimal intracranial hemorrhage, relying solely on clinical symptom observation and monitoring is insufficient. Timely and close monitoring with cranial CT is crucial for the early detection of progressive intracranial hemorrhage.

100 Deals associated with Cellulose Oxidized

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Indication	Country/Location	Organization	Date
Hemorrhage	JP	Johnson & Johnson	21 Dec 1972

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 3	-	Corza Medical GmbH	25 Nov 2024

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