Cancellous Bone Bleeding Clinical Trial in Hyderabad, India
- By St. Teresa Medical
- Press Releases
June 21, 2016 - Eagan, MN - On June 1, 2016, St. Teresa Medical, Inc has successfully treated 10 patients in its hemostasis clinical trial in India. The study was designed to provide additional safety and performance data on the ability of the SURGICLOT® Hemostatic Dressing to achieve hemostasis of cancellous bone bleeding. All ten patients treated with SURGICLOT® underwent elective spinal fusion surgery. SURGICLOT® was applied to the bleeding surface of one or two spinal segments. Bleeding severity at each SURGICLOT®-treatment site ranged from oozing to flowing. A total 12 bleeding sites were treated with SURGICLOT®. At all treatment sites, application of a single SURGICLOT® dressing for 3 minutes successfully stopped the bleeding.
The spine surgeries were performed at STAR Hospital in Hyderabad, India by Dr. Sukumar Sura (Principal Investigator), Dr. Sai Sudarsan and Dr. Bala Raja Shekar. Upon completion of the study, Dr. Sura sent an email to St. Teresa regarding the use and performance of SURGICLOT®. Dr. Sura made the following comments about the study:
It was nice to be associated with your clinical research study. SURGICLOT® is phenomenal and performed far better than other products I have used as hemostats, e.g., bone wax, Gelfoam®, Floseal®, etc., during spine surgeries, especially for cancellous bone bleeding. Application of SURGICLOT® is simple and easy and does not interfere with completion of the surgical procedure. Another great feature of the product is that it dissolves fast and hemostasis is absolute.
After using SURGICLOT® in 10 spinal fusion cases, I now have additional ideas and potential areas where SURGICLOT®can be used, e.g., in cases of large brain tumors (meningiomas and gliomas) to prevent tumor bed hematomas.
I am also looking forward to starting the dural repair clinical study once the follow-up visits of our subjects in the current study are completed in July 2016.
Overall, this product is here to stay and will be a good addition to the hemostasis armamentarium available for neurosurgery in the future."
The trial was conducted by 8C Healthcare Pvt. Ltd., # 1207, 13th Street, Vijaya Bank Road, Gandhi Nagar,Hyderabad, Telangana, India 500080