Safety and effectiveness of Evicel fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery.

Purpose: Cerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel fibrin sealant as an adjunct to primary dural suturing in children undergoing cranial surgery.

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

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).

A symmetric anchor designed barbed suture versus conventional interrupted sutures in total knee arthroplasty: A multicenter, randomized controlled trial.

Objective: This randomized controlled study was designed to compare the wound closure efficacy and safety of barbed suture in comparison to the conventional interrupted suture for total knee arthroplasty (TKA).

Methods: This multicenter, single-blind, randomized controlled trial enrolled 184 patients who underwent elective TKA between June 2017 and April 2018. The subjects were randomized between two groups.

Preclinical evaluation of the effect of the combined use of the Ethicon Securestrap Open Absorbable Strap Fixation Device and Ethicon Physiomesh™ Open Flexible Composite Mesh Device on surgeon stress during ventral hernia repair.

Aim: To evaluate whether performing ventral hernia repairs using the Ethicon Physiomesh™ Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap Open Absorbable Strap Fixation Device reduces surgical time and surgeon stress levels, compared with traditional surgical repair methods.

Methods: To repair a simulated ventral incisional hernia, two surgeries were performed by eight experienced surgeons using a live porcine model. One procedure involved traditional suture methods and a flat mesh, and the other procedure involved a mechanical fixation device and a skirted flexible composite mesh.

Hemostasis during urologic surgery: fibrin sealant compared with absorbable hemostat.

In the United States, fibrin sealants have been used to achieve hemostasis for nearly two decades. Although their clinical utility was first demonstrated in cardiac surgery, their effectiveness and safety have since been demonstrated to extend to a wide array of procedures. Fibrin sealants typically contain two components-fibrinogen and thrombin-that are combined and delivered simultaneously to a target bleeding site in order to achieve hemostasis.

Clinical evaluation of a third-generation thermal uterine balloon therapy system for menorrhagia coupled with curettage.

Study Objectives: To estimate the incidence of amenorrhea 12 months after treatment with a third-generation thermal uterine balloon therapy (UBT) system. Secondary objectives were to compare the incidence of amenorrhea observed with this third-generation system with that of a first-generation system, to estimate the effect of postprocedure curettage on patient outcome, and to evaluate the workings of this new system.

Design: Multicenter, controlled study (Canadian Task Force classification I).

A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery.

Purpose: Adequate hemostasis is necessary after endoscopic sinus surgery. This study evaluated the clinical performance of Surgiflo hemostatic matrix (Johnson&Johnson Wound Management, a division of Ethicon Inc, Somerville, NJ) with Thrombin-JMI (distributed by Jones Pharma Inc, Bristol, VA, a wholly owned subsidiary of King Pharmaceuticals, Bristol, TN) in achieving hemostasis in patients undergoing endoscopic sinus surgery. Surgiflo hemostatic matrix is a sterile, absorbable porcine gelatin intended to aid with hemostasis when applied to a bleeding surface.