Adhesive-enhanced sternal closure to improve postoperative functional recovery: a pilot, randomized controlled trial.

BACKGROUND: We previously established a proof-of-concept in a human cadaveric model where conventional wire cerclage was augmented with a novel biocompatible bone adhesive that increased mechanical strength and early bone stability. We report the results of a single-center, pilot, randomized clinical trial of the effects of adhesive-enhanced closure of the sternum on functional postoperative recovery. METHODS: In 55 patients undergoing primary sternotomy, 26 patients underwent conventional wire closure and were compared with 29 patients who underwent adhesive-enhanced closure, which consisted of Kryptonite biocompatible adhesive (Doctors Research Group Inc, Southbury, CT) applied to each sternal edge in addition to conventional 7-wire cerclage. Patients were monitored postoperatively at 72 hours, weekly for 12 weeks, and then after 12 months for incisional pain, analgesic use, and maximal inspiratory capacity measured by spirometry. Standardized assessment tools measured postoperative physical disability and health-related quality of life. RESULTS: No adverse events or sternal complications from the adhesive were observed early or after 12 months. Incisional pain and narcotic analgesic use were reduced in adhesive-enhanced closure patients. Inspiratory capacity was significantly improved, postoperative health-related quality of life scores normalized more rapidly, and physical disability scores were reduced. Computed tomography imaging was suggestive of sternal healing. CONCLUSIONS: Adhesive-enhanced closure is a safe and simple addition to conventional wire closure, with demonstrated benefits on functional recovery, respiratory capacity, incisional pain, and analgesic requirements. A large, multicenter, randomized controlled trial to examine the potential of the adhesive to prevent major sternal complications in higher risk patients is warranted.

Enhancing sternal closure using Kryptonite bone adhesive: technical report.

A novel approach to enhance the mechanical stability of primary sternal closure is described. An osteoconductive bone adhesive is used to augment conventional wire cerclage. More than 30 patients have undergone primary sternal closure using Kryptonite bone adhesive. All patients recovered well with no adverse side effects or adhesive-associated complications. Adhesive-enhanced sternal closure may accelerate functional recovery after sternotomy, improve early outcomes and prevent major sternal complications such as deep sternal wound infection and dehiscence. The technique is simple, safe, and expedient.

Kryptonite bone cement prevents pathologic sternal displacement.

BACKGROUND: Wire cerclage closure of sternotomy is the standard of care despite evidence of pathologic sternal displacement (> 2 mm) during physiologic distracting forces (coughing). Postoperative functional recovery, respiration, pain, sternal dehiscence, and infection are influenced by early bone stability. This translational research report provides proof-of-concept (part A) and first-in-man clinical data (part B) with use of a triglyceride-based porous adhesive to rapidly enhance the stability of conventional sternal closure. METHODS: In part A, fresh human cadaver blocks were subjected to midline sternotomy and either conventional wire closure or modified adhesive closure. After 24 hours at 37 degrees C, using a biomechanical test apparatus, a step-wise increase in lateral distracting force simulated physiologic stress. Sternal displacement was measured by microdisplacement sensors. In part B, a selected clinical case series was performed and sternal perfusion assessed by serial single photon emission computed tomography imaging. RESULTS: Wire closure resulted in measurable bony displacement with increasing load. Pathologic displacement (> or = 2 mm) was observed in all regional segments at loads 400 newton (N) or greater. In contrast, adhesive closure completely eliminated pathologic displacement at forces 600 N or less (p < 0.001). In patients, adhesive closure was not associated with adverse events such as adhesive migration, embolization, or infection. There was excellent qualitative correlation between cadaver and clinical computed tomographic images. Sternal perfusion was not compromised by adhesive closure. CONCLUSIONS: This first-in-man series provides proof-of-concept indicating that a novel biologic bone adhesive is capable of rapid sternal fixation and complete elimination of pathologic sternal displacement under physiologic loading conditions. A randomized clinical trial is warranted to further define the potential risks and benefits of this innovative technique.