Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform.

Many medical conditions require chronic treatment with subcutaneous injectable biologics often exceeding 1.0 mL. However, subcutaneous administration of volumes of 2.0 mL or greater using a standard needle and syringe or auto-injector proves challenging, and patients often must administer two separate injections to achieve their full dose or endure injection times in excess of 10 s if using a mechanical autoinjector. In addition, needle-based injections often cause patient anxiety and discomfort. In this article, we describe an approach to meet these needs with a needle-free medication delivery device capable of rapidly delivering up to 2.0 mL with minimal discomfort. A pilot study was conducted with this needle-free injection system to evaluate the delivery of a 2.0 mL volume in human subjects. The results demonstrated that injections of up to 2.0 mL were well tolerated and often preferred over two separate 1.0 mL injections using the needle-free injection system.

Advances in subcutaneous injections: PRECISE II: a study of safety and subject preference for an innovative needle-free injection system.

Needle-free injection is a desirable goal for many reasons, including reducing pain, anxiety, and eliminating safety risks associated with needle-stick injuries. However, development of a safe, reliable needle-free device optimized for at-home use has been met with many challenges. Portal Instruments Inc. has been developing needle-free medication delivery using a well-designed hand-held device, PRIME, that is safe, intuitive to use, and utilizes advanced electronic control of a focused, high velocity, pressurized liquid injection stream. The PRECISE II human study demonstrated that the PRIME needle-free injection system was safe, well tolerated, and strongly preferred by participants for self-injections over a standard needle and syringe. In addition, the study was able to be completed early for superiority following the success of the pre-defined interim analysis.

A randomized trial of a skin sealant to reduce the risk of incision contamination in cardiac surgery.

BACKGROUND: Immobilizing skin microbes is a rational approach to reducing contamination of surgical sites by endogenous microorganisms. METHODS: This randomized, controlled, parallel-group, multicenter, open-label clinical trial (ClinicalTrials.gov NCT00467857) enrolled 300 adults scheduled for elective coronary artery bypass graft surgery. Patients received iodine-based skin preparations followed by a cyanoacrylate-based skin sealant or skin preparations alone. Microbiological samples collected from sternal and graft incision sites immediately before any skin preparation, at the wound border after skin incision, and at the incision after fascial closure were evaluated quantitatively. RESULTS: In evaluable patients, mean microbial counts in collected samples increased at the sternal site after fascial closure compared with after skin incision by 0.37 log10 colony-forming units (CFU)/mL in the skin sealant group (n=120) and by 0.57 log10 CFU/mL in the control group (n=132) (p=0.047, Wilcoxon rank sum test). At the graft site, mean microbial counts increased by 0.09 (n=119) and 0.27 (n=127) log10 CFU/mL, respectively (p=0.037). There was a 35.3% relative risk reduction in surgical site infection (SSI) occurring in the skin sealant group (9 of 146 patients, 6.2%) versus the control group (14 of 147 patients, 9.5%). In obese patients (body mass index [BMI]>30.0 to ≤37.0 kg/m2), the relative risk reduction for SSI associated with skin sealant was 83.3%. CONCLUSIONS: Pretreatment with skin sealant protects against contamination of the surgical incision by migration of skin microbes. Further data are needed to confirm the impact of this technology on SSI rates in clinical practice.