News
Article
Author(s):
A 25-day BioLab study revealed their protein-rich wound gel outpaces alternatives, setting the stage for clinical trials.
BioLab Holdings, Inc., a Phoenix-based manufacturer specializing in wound care products, recently conducted a 25-day preclinical study to evaluate a new wound care product. The product, described as a gelatinous skin formulation with a high protein concentration, is designed to contour to wounds and does not require a donor biopsy. The study aimed to assess the product’s safety, efficacy, and its potential to improve wound healing outcomes compared to a competitor product and a saline control.1
"This is our latest innovation in wound care – a gelatinous skin product that contours to the wound and has a high protein concentration," said Carlos Encinas, PhD, MBA, chief science officer for BioLab in a news release. "The product does not require donor biopsy, and we believe it will be a game changer for wound treatment. We hope to launch the product later this year."
The study was conducted using a porcine model, with 25 animals divided into 3 groups: 1 treated with the test product, another with a competitor product (referred to as the reference Item), and a control group receiving saline solution. Wounds on the animals' backs were monitored over short-, mid-, and long-term periods. Researchers collected data through wound measurements, photographs, and dressing assessments while monitoring animal welfare. Blood samples were taken to evaluate biochemistry, hematology, and hepatic and renal biomarkers.
Study Findings
The study revealed that the test product demonstrated faster wound healing in long-term evaluations compared to the reference Item and control groups. Short-term healing differences were minimal across all groups. Secondary parameters such as exudate, scab formation, and infection rates showed no significant differences among groups, indicating that the new product did not negatively impact these factors.
The topical application of the test product was reported to be well-tolerated over the course of the study, with no adverse effects observed in the treated animals.
Study Design
The study adhered to good laboratory practices (GLP) and ISO 13485:2016 standards. Independent inspections were conducted to ensure regulatory compliance, and no findings compromised the integrity of the results. The researchers highlighted that the study focused on evaluating wound healing and safety, providing a foundation for future clinical investigations.
Conclusion
While the test product showed promise in improving long-term wound healing, researchers stated further studies, including clinical trials, are necessary to validate its efficacy and safety in human applications. These findings represent an initial step in the product’s development and potential commercialization.
Background
BioLab offers a range of products, including Membrane Wrap Lite, Tri-Membrane Wrap, Membrane Wrap, and Membrane Wrap - Hydro, which utilize human tissue allograft derived from the amniotic membrane. These minimally manipulated products retain the tissue's natural properties, providing structural support as wound protectant coverings.2
References