Vomaris Wound Care, Inc., a regenerative medical device company specializing in microcurrent field generating technologies for the wound care market, announced that in an effort to identify improved options for wound care, a clinical study to investigate Procellera® Wound Dressing on acute wound healing in U.S. Army Rangers has been launched at the U.S. Army 4th Ranger Training Brigade (RTB) in Fort Benning, Georgia.
The $1 million research initiative is funded by a grant from the U.S. Army Medical Materiel Command (USAMMA) and includes collaborators, such as The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), and its Diagnostics and Translational Research Center (DTRC).
The randomized two-arm study will involve up to 80 Rangers. The study is designed to evaluate the efficacy of Procellera versus the current Army methods. Procellera is already available to the public and is used in hospitals, as well as available over-the-counter.
“The Army Rangers are some of the most elite members of our Armed Forces, and deserve to be equipped with the very latest in advanced wound care technology for frontline treatment,” said Michael P. Nagel, Vomaris President and CEO. “Procellera will be put to the test in the toughest of conditions. For the past three years, our company has enjoyed a very collaborative effort with the U.S military on testing and performance of our product. We look forward to the results from this critical trial.”
Skin injuries, including cuts, blisters and abrasions, are a common occurrence in military populations that are at high risk for developing infectious complications which become duty-limiting and account for training time losses, attrition and medical costs.
“The USAMMA is extremely grateful to the Fort Benning community, participants, physicians, medics, and researchers who have made this important field product evaluation possible,” said Greggory J. Housler, a Biomedical Engineer/Product Manager at USAMMA.
Researchers also aim to investigate wound healing on a cellular level through wound cytokine and chemokine analysis, as well as microbial colonization.
“Ultimately, we hope data from this study can help keep future service members healthier in training and on the battlefield,” said Nagel. “New technologies that can reduce healing times and improve quality of life could revolutionize wound care, improve military medicine, and possibly increase military readiness on a significant scale.”
The study is expected to end in mid-2014. HJF will provide data management, regulatory, and site monitoring support to the study team, and its researchers at the DTRC will provide quantitative analysis on biomarkers and bacteriology. Vomaris will supply product, technical and scientific support regarding the use of Procellera.
HJF researchers have already presented three abstracts on Procellera’s antimicrobial efficacy and its use as a next-generation wound care product in the battlefield at the Symposium on Advanced Wound Care in Las Vegas in September.
In addition to this study, research is ongoing at the Complex Wound and Limb Salvage Center at Walter Reed National Military Medical Center to investigate the use of Procellera compared to standard of care in the treatment of non-healing soft tissue wounds.